Inspection tracker: Drug manufacturing establishments

As part of Health Canada's ongoing commitment to openness and transparency, the Department is publishing information regarding emerging issues identified through our drug inspection program.

This tracker provides a snapshot of the potential health and safety issues Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada. The information in the chart will expand to eventually include details about affected Canadian companies and products.

How the inspection tracker works

Health Canada responds to potential risks as soon as we hear about them whether from our own inspections, the companies themselves, adverse reaction reports or from our regulatory partners.
The tracker highlights actions Health Canada is taking such as: requests for voluntary quarantine, stop sales, import restrictions, or product recalls. It also indicates those circumstances where no action has been warranted.
Even if a company is listed on the tracker, it doesn't necessarily mean there is an immediate risk to the health of Canadians. It means Health Canada is looking into a potential issue.
Health Canada will continue to take action to manage risks identified to the health of Canadians using the most appropriate level of intervention, proportional to the risk to health.
This tracker currently doesn't list specific drugs and health products affected but links to Recalls and Safety Alerts if a risk has been linked to specific products on the Canadian market.
This tracker is updated regularly.
Once an item is listed in the closed section, it indicates that there is no further action being taken by Health Canada at this time and there will be no more updates regarding this item.
Last update: April 10, 2024

Open items
Establishment	Status of issue	Source of information under review	Primary reason for action
Bell International Laboratories, Inc. 2950 Lexington Avenue South, Eagan, MN, 55121, United States New	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner	Regulatory Partner(s)	General GMP observations
Cosmetic Solutions, LLC 6101 Park of Commerce Blvd, Boca Raton, FL, 33487, USA New	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner	Regulatory Partner(s)	General GMP observations
Givaudan – Lavirotte 56 Rue Paul Cazeneuve, Lyon, 69008, France	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Haiman Pharma Inc. No. 163, Zhuhai Road, Binjiang Street, Haimen City, Jiangsu, 226100, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Pharma Nobis LLC 7400 Alumax Drive Texarkana TX United States 75501	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Saga Lifesciences Survey No. 198/2 And 198/3, Chachrawadi Vasna, Ta Sannand, Ahmedabad, 382210, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations

Closed items
Establishment	Status of issue	Source of information under review	Primary reason for action
Cipla Limited Plot No. 9&10, Indore Special Economic Zone, Phase II, Section III, Pithampur, District Dhar, Madhya Pradesh, 454775, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Intas Pharmaceuticals Limited Plot No. 457-458 & 191/218P, Sarkhej Bavla Hwy, Matoda, Sanand, Ahmedabad, Gujarat, 382 210, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
K.C. Pharmaceuticals Inc. 3215 Producer Way, Pomona, CA, USA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Centaur Pharmaceuticals Private Ltd Plot No.4, International Biotech Park, Phase-II, Hinjewadi, Pune, Maharashtra, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Baxter Pharmaceuticals India Pvt. Ltd. Village Vasana Chacharwadi, Taluka Sanand, Ahmedabad, India.	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Beximco Pharmaceuticals Ltd. Vision Unit, 126 Kathaldia Auchpara, Tongi, Gazipur, 1711, Bangladesh	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Medgel Private Limited Special Economic Zone, Phase-II, Sector-III, Pithampur, Dist. Dhar (M.P.), India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Sun Pharmaceutical Industries Limited A-41 Industrial Area, Phase VIIIA, SAS Nagar Mohali, Punjab, 160071, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Lupin Limited Unit 1 Unit 1, 198-202 New Ind Area No 2, Mandideep Madhya Pradesh, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) Health Canada on-site inspection [2023-03-13] No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Intas Pharmaceuticals Limited Plot No. 5 to 14, Pharmez, Sarkhej-Bavla, National Highway No. 8-A, Near Village Matoda, Taluka Sanand, Ahmedabad, Gujarat, 382 213, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Accra Pac Inc. dba Voyant Beauty 1919 Superior Street, Elkhart, IN, 46516-4707, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Advanced Cosmetic Research Laboratories Inc 20550 Prairie St, Chatsworth, CA, 91311, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cangene BioPharma LLC dba Emergent BioSolutions 1111 South Paca Street, Camden Industrial Park, Baltimore, MD, 21230, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Centaur Pharmaceuticals Pvt Ltd Plot No. 75, 76 and 76/1 Chikhloli MIDC, Ambernath (West), Dist. Thane, Maharashtra, 421501, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Centrient Pharmaceuticals India Private Limited Bhai Mohan Singh Nagar, Toansa, Distt.SBS, Nagar (Nawanshahr), Punjab, 144 533, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Glenmark Pharmaceuticals Limited Plot No. S-7, Colvale Industrial Estate, Colvale, Bardez, Goa, 403513, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Jurox Pty Ltd. 85 Gardiner Street, Rutherford, New South Wales, 2320, Australia	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Abraxis Bioscience LLC 620 N. 51st Avenue, Phoenix, AZ, 85043, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Accu Bio-Chem Laboratories 1755 Victory Boulevard, Glendale, CA, 91201, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Akorn Inc. 1222 West Grand Ave Decatur, IL USA, 62522-1412	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Akorn Inc. 72 Veronica Ave, Somerset NJ, 08873, USA	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Acharya Chemicals W41 &W42, MIDC Industrial estate - Morivali Village, 421501 AMBARNATH (W) (Dist Thane), 42150, India	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Actavis Laboratories, FL. Inc., 4955 Orange Drive, Davie, Fort Lauderdale, Florida, USA, 33314	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified. Issued terms and conditions to Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Advanced Accelerator Applications USA, Inc. 57 East Willow Street, Millburn, NJ, 07041, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Agila Onco Therapies Ltd. Plot No. 284/B Bommasandra Jigani Link Road, Industrial Area, Bangalore, Kamataka, India	Non-compliant rating issued No further action required by Health Canada at this time Related recalls and alerts: Methotrexate Injection USP 50 mg/2 mL - Voluntary Recall Due to the Potential Presence of Foreign Particulate Matter	Regulatory Partner(s) Canadian importer(s)	General GMP observations
AGILA SPECIALTIES PRIVATE LTD. Opp II M, Bilekahalli, Bannerghatta Road, Bangalore, Karnataka, India - 560 076	Canadian importer(s) contacted by Health Canada for information No critical risks identified to date No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
AGILA SPECIALTIES PRIVATE LTD., SPECIALTY FORMULATION FACILITY (SFF) 19A, Plot No. 284-B/1 Bommasandra Jigani Link Road, Anekal Taluk, Bangalore India - 560 105	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Requested voluntary quarantine of non-medically necessary products Voluntary quarantine in place Issued terms and conditions to Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
AllerQuest LLC 10 Farmington Valley Drive, Suite 106 Plainville, Connecticut 06062-1182, United States	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Terms and Conditions applied	Regulatory Partner(s)	General GMP observations
Amanta Healthcare Ltd. Plot No 876 NH No 8, Hariyala Matar Kheda, Gujarat, 387411, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued terms and conditions to Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Antibioticos do Brasil Rod. Professor Zeferino Vaz, Km135-SP332, Cosmopolis, Sao Paulo, Brazil 13150-000	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued terms and conditions to Canadian importer(s)	Regulatory Partner(s)	General GMP observations
Anuh Pharma Ltd E-17/3 & E 17/4 M.I.D.C. Tarapur, Taluka Palghar, District Thane, India-401 506 Boisar, Maharashtra	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Apotex Pharmachem India Private Limited (APIPL) Plot No. 1A, Bommasandra Industrial Area, 4^th Phase, Jigani Link Road, Bangalore, Karnataka, India	Requested stop sale Import restrictions imposed On September 30, 2014, Issued Terms and Conditions to Canadian importer(s) Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) HC onsite (June 5-10) to verify implementation of corrective actions On August 31, 2015, amended Terms and Conditions to Canadian importer based on HC onsite corrective actions inspection conducted on June 5-10 Judgments of the Federal Court set aside import restrictions on APIPL and ARPL products, ordered a retraction of statements and declared amended terms and conditions on Apotex's Establishment Licence unlawful. Related recalls and alerts: Health Canada puts measures in place for medically necessary products affected by import restriction from 3 facilities in India Apotex Product Recall (2015-04-10) Expanded recall of Apo-Candesartan Health Canada puts in place new oversight of Apotex Inc. imports from APIPL and ARPL Summary Report March 14, 2016: Health Canada issued a new decision which imposed no terms and conditions on Apotex's Establishment Licences for products fabricated at APIPL and ARPL. As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex.	Health Canada Regulatory Partner(s)	Data integrity General GMP observations
Apotex Research Private Limited (ARPL) Plot No. 1 and No. 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bangalore, India	Voluntary quarantine was in place until further assessment was completed Import restrictions imposed On September 30, 2014, issued Terms and Conditions to Canadian importer(s) Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) HC onsite (June 1-4) to verify implementation of corrective actions On August 31, 2015, amended Terms and Conditions to Canadian importer based on HC onsite corrective actions inspection conducted on June 1-4. Judgments of the Federal Court set aside import restrictions on APIPL and ARPL products, ordered a retraction of statements and declared amended terms and conditions on Apotex's Establishment Licence unlawful. Related recalls and alerts: Health Canada requests quarantine of products for Canadian market from Apotex facility in Bangalore, India Health Canada puts measures in place for medically necessary products affected by import restriction from 3 facilities in India Apotex Product Recall (2015-04-10) Expanded recall of Apo-Candesartan Recall of Apo-Candesartan-HCTZ Apo-Risperidone (2015-06-03) Losartan-HCTZ (2015-06-03) Health Canada puts in place new oversight of Apotex Inc. imports from APIPL and ARPL Summary Report March 14, 2016: Health Canada issued a new decision which imposed no terms and conditions on Apotex's Establishment Licences for products fabricated at APIPL and ARPL. As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex.	Health Canada Regulatory Partner(s)	Data integrity General GMP observations
Apotex Research Private Limited (ARPL) Plot No. 1 and No. 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bangalore, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Aurobindo Pharma Limited Unit-1, Sy. No. 379, 385, 386, 388-396, Borpatla Village, Hatnoora Mandal, Sangareddy District, Telangana, 502296, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Aurobindo Pharma Ltd, Unit 11, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, 532409, India	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified. Issued terms and conditions to Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
B. Braun Medical Inc. 2525 McGaw Avenue Irvine, CA, 92614-5895 United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Baxter HealthCare Corp Jayuya Plant, 250 State, Road 144, Jayuya, PR, 664, United States	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Bayer S.A Km 14.5 Calzada Roosevelt, Zona 3 De Mixco, Guatemala, N/A, 1901, Guatemala	Canadian importer(s) contacted by Health Canada for information Medically necessary products identified Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Issued terms and conditions to Canadian importer(s)	Regulatory Partner(s)	Data integrity General GMP observations
Beauty Manufacturing Solutions Corp. 1250 Freeport Parkway, Coppell, Texas	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Beijing Taiyang Pharmaceutical Industry Co Ltd No. 1 Shuangqiao (E) Road, Chaoyang, Beijing China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Bend Research Inc 20503 Builders Street, Bend, Oregon, USA, 97701	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued terms and conditions to Canadian importer(s) Removed Terms and Conditions from Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Bharat Biotech International Limited Sy. No. 230, 231 and 235, Turkapally, Telangana, India, 00078	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Biocon Limited, Works Unit II Plot Nos 2-4, Phase IV, Bommasandra-Jigani Link Road Bangalore, Karnataka India 560099	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Bioiberica S.A.U. C/Antic Cami de Tordera, 109-119, Palafolls, Barcelona, 08389, Spain	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cadila Pharmaceuticals Limited. 294, G.I.D.C. Industrial Estate, Ankleshwar, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No critical risks identified to date Health Canada on-site inspection [July 18, 2016] Health Canada on-site re-inspection [January 23, 2017] No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Celltrion, Inc. 23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cetylite Industries 9051 River Road, Pennsauken, NJ, USA, 08110	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
ChemRite CoPac Inc. 19725 W. Edgewood Dr., Lannon, WI, USA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cheng Fong Chemical Co. Ltd. No. 19, Gong 4th Road, Dayuan district, Taoyuan City 337, Taiwan	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Issued terms and conditions to Canadian importer(s)	Regulatory Partner(s)	General GMP observations
Chongqing Pharma Research Institute Co., Ltd. No. 565 Tushan Road, Nanan District, Chongqing, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Cipla Limited Unit III L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cipla Limited Unit IV L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cipla Limited Unit VIII, S-103 To S-105, S-107 To S-112, L-147, L-147/1 & L-147/3	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cipla Limited Unit X L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India	Canadian importer contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Claris Injectables Limited Chacharwadi, Vasna, Sarkhej Bavla Road Ahmedabad, Gujarat India, 382213	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Concord Biotech Limited 1482-1486 Trasad Road, Dholka Ahmedabad, Gujarat 387810, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Continental Manufacturing Chemist, Inc. 912 S. State St., Madrid, Iowa	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Cosmax USA 30701 Carter Street, Solon, OH, 44139, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
CTX Life Sciences Pvt. Ltd. 251-252 Sachin-Magdalla Road, G.I.D.C, Sachin, Surat, Gujarat, India, 394230	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
CTX Lifesciences Private Ltd. Block No. 251-252 Sachin-Magdalla Road, GIDC, Sachin, Surat 394230 Gujarat, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Health Canada remote inspection [2022-02-03] No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
CuraTeQ Biologics Private Limited Sy. No. 77 & 78, Indrakarn (V), Kandi (M), Sanagareddy (D), Hyderabad, Telangana, 502329, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Denison Pharmaceuticals, LLC 1 Powder Hill Rd.Lincoln, RI 02865 United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Dishman Carbogen Amcis Limited Located at Survey No. 47 & 48, Paiki Sub Plot No. 1, Taluka Sanand, District Ahmedabad, Village Lodariyal, Gujarat, 382 220, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Divi's Laboratories Ltd. Unit 2, Chippada Village, Bheemunipatnam, Visakhapatnam, Andhra Pradesh, 531 162, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued terms and conditions to Canadian importer(s) Health Canada on-site inspection [November 13, 2017] No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Dr. Reddy's Laboratories APIIC Ind. Est, Unit VI Pydibhimavarma (Village) Ranasthalam Mandal, Srikakulam District, India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place Issued terms and conditions to Canadian importer(s) Health Canada on-site inspection [September 19, 2016] No further action required by Health Canada at this time Related recalls and alerts: Health products quarantined from two sites in India as Health Canada assesses data integrity concerns	Regulatory Partner(s)	Data Integrity General GMP observations
Dr. Reddy's Laboratories Unit V Peddadevulapalli, Tripuraram Mandal, Nalgonad District, Andhra Pradesh	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Dr. Reddy's Laboratories Unit VII Plot No. P1 to P9, Phase III, Duvvada, VSEZ, Visakhapatnam, Andhra Pradesh IN	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this timeNo further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Ei LLC 2865 N. Cannon Blvd., Kannapolis, North Carolina 28083-9124, US	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Emcure Pharmaceuticals Limited Plot No. P-1 & P-2,, IT-BT Park Phase II, MIDC, Hinjwadi, Hinjwadi, Pune, Maharashtra INDIA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) Medically necessary products identified Health Canada on-site inspection [June 14, 2016] No further action required by Health Canada at this time	Regulatory Partner(s) Canadian importer(s)	Data Integrity General GMP observations
Emergent Manufacturing Operations Baltimore, LLC 5901 East Lombard Street, Baltimore, MD, 21224, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Issued terms and conditions to Canadian importer(s) Health Canada on-site inspection [2021-10-25] No further action required by Health Canada at this time Related statement	Regulatory Partner(s)	General GMP observations
Emergent Manufacturing Operations Baltimore, LLC 5901 East Lombard Street, Baltimore, MD, 21224, United States Date of information received: 2022-02-07	Canadian importer(s) contacted by Health Canada for information Import restrictions imposed No further action required by Health Canada at this time	Foreign Building Canadian Importer(s)	General GMP deficiencies
EVERLIGHT CHEMICALS INDUSTRIAL CORPORATION 12, Industrial Third Rd, Kuanyin Industrial District, Kuanyin Hsiang, Taoyuan Hsien, 32853, Taiwan	Canadian importer(s) contacted by Health Canada for information No medically necessary products identified at this time Health Canada on-site inspection (November 9-13, 2015) Non-Compliant rating issued No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Evertogen Life Sciences Limited PLOT NO: S-8, S-9, S-13/P & S-14/P TSIIC, Pharma Sez Green Industrial Park, Polepally (V), Jadcherla (M), Mahabubnagar, Telangana, IN-509 301, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations Data Integrity
Felix Generics Private Limited Plot No. M-24, 25, 26 & 27, Special Economic Zone, Phase II, Pithampur, Dhar, Madhya Pradesh, 454775, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Glenmark Pharmaceuticals Limited Village Kishanpura Baddi Nalagarh Road Baddi Solan, Himachal Pradesh, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Glenmark Pharmaceuticals Limited, Unit I Village Kishanpura, Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh India Inspection start date: 2022-06-13	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Gordon Laboratories, Inc 751 E. Artesia Blvd, Carson, CA, 90746, United States)	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Granules India Limited Plot No. 160/A, 161/E, 162 & 174/A, Gagillapur Village, Qutbullapur Mandal, Ranga Reddy District, Telangana state, Hyderabad, 500043, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s	General GMP observations
Guangzhou Tinci Materials Technology Co. Ltd. No.8 Kangda Road, Yunpu Industrial Zone, Huangpu Region	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
HEBEI YUXING BIO-ENGINEEERING CO. LIMITED Xicheng District, Ningjin county, Ningjin, Heibei China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine of non-medically necessary products Voluntary quarantine in place No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Henan Lihua Pharmaceutical Co., Ltd. Middle Of Huanghe Street, Anyang, Henan CHINA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further actions required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Hetero Labs Ltd. Unit I Survey No 10 I.D.A., Gaddapotharam Village, Jinnaram Mandal, 502 319, Medak District, Telangana, India	Canadian importer(s) contacted by Health Canada for information Health Canada has completed a GMP assessment and assessed the site as non-compliant. Medically necessary products identified. Importers cannot import active pharmaceutical ingredients or drug products that contain active pharmaceutical ingredients from this site. Health Canada is continuing to review information as it becomes available. No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Hetero Labs Limited Unit V Sy.No.439-441, 458 TSIIC Formulation SEZ Polepally Village, Jadcherla Mandal Mahaboobnagar, Telangana India 509301	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Hetero Labs Limited Survey No. 10, I.D.A., Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, 502 319, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Hospira Inc. 1776 North Centennial Drive, McPherson, KS, United States, 67460-9301	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [July 24, 2017] No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Hospira S.P.A Via Frosse Ardeatine 2 LIscate Italy	Canadian importer(s) contacted by Health Canada for information Medically necessary products identified Requested voluntary quarantine Voluntary quarantine not accepted due to products being medically necessary Issued Terms and Conditions to Canadian importer(s) Related recalls and alerts: Health Canada restricts imports of drugs from Hospira S.P.A, Italy due to data integrity concerns	Regulatory Partner(s)	Data integrity General GMP observations
Hubei Hongyuan Pharmaceutical Technology Co. Ltd. No. 428 Yishui North Road, Luotian County, Huanggang City, China-438 600, Fengshan Town, Hubei Province	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Hubei Hongyuan Pharmaceutical Technology Co. Ltd. No.8 Fengshan Road, Industrial and Economic Development Zone, Luotian County, China 438 600, Huanggang City, Hubei Province	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
IDT Australia Ltd. 45 Wadhurst Drive Boronia, Victoria Australia	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further actions required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Imaretcioglu llac Sanayi Ltd. Sti. Samsun Serbest Bolgesi Subesi Serbest Bolge, E Ada, 2 Parsel, Limanici, Samsun, Turkey	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
ImClone Systems LLC 50 ImClone Drive, Branchburg NJ, 08876, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Ind-Swift Laboratories Limited Barwala Road, Bhagwanpur Village - Derabassi District Mohali, 140 507 Punjab, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No critical risks identified to date No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Indoco Remedies LimitedT L-14, Verna Industrial Area, Verna, IN-403 722, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Indoco Remedies Limited Plants II & III, L-32, 33, 34 Verna Industrial Estate Area, Verna, Goa, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Indoco Remedies Limited - Plant II L-32, 33, 34 Verna Industrial Area, Verna, India, 403722	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Instituto Massone S.A. Arias 4431, Buenos Aires, 1430, Argentina	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Intas Pharmaceuticals Limited (IPL) Plot No. 423 / P / A Sarkhej - Bavla Highway Village Moraiya, Taluka Sanand Ahmedabad - 382213 Gujarat, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Interpharm Praha A.S. Komoranska 955, Praha, Modrany	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) Issued Terms and Conditions to Canadian importer(s)	Regulatory Partner(s)	General GMP observations
INTERQUIM, S.A., C/ Joan Buscalla, 10 Sant Cugat del Valles Barcelona, Spain	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) Issued Terms and Conditions to Canadian importer(s) Terms and Conditions removed No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
IPCA Laboratories Ltd Plot 65 & 99, Dandudyog Industrial Estate, Piparia, Silvassa, Dadra & Nagar Haveli (U.T.), 396 230, India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Terms and Conditions for IPCA Ratlam apply to the Piparia products. Health Canada on-site inspection [August 19, 2016] No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
IPCA Laboratories Ltd. 1 Pharma Zone, SEZ Phase II, Sector 3, District Dhar, Pithampur, India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place Issued terms and conditions to Canadian importer(s) Health Canada on-site inspection [October 3, 2016] No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
IPCA Laboratories Ltd. P.O. Box No. 33 Village Sejavta Ratlam, Madya Pradesh, India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Requested voluntary quarantine Voluntary quarantine in place Import restrictions imposed Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [September 26, 2016] No further action required by Health Canada at this time Related recalls and alerts: Health Canada requests quarantine of products from IPCA Laboratories following falsification and manipulation of data issues Health Canada puts measures in place for medically necessary products affected by import restriction from 3 facilities in India	Regulatory Partner(s)	Data integrity General GMP observations
Jiangxi Dongfeng Pharmaceutical Co., Ltd 1 Dongfeng Road, Leping Industrial Park, Leping City, Jiangxi Province, 333300, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Jiangxi Synergy Pharmaceutical Co., Ltd. Jiangxi Fengxin Industrial Park, China-330 700, Fengxin, Jiangxi Province	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No critical risks identified to date No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Jilin Shulan Synthetic Pharmaceutical Co. Ltd. No. 2066 Peoples Main Road, Shulan, Jilin - China	Canadian importer(s) contacted by Health Canada for information Foreign building refused to provide GMP evidence to Importer or Health Canada for assessment No further action required by Health Canada at this time	Regulatory Partner(s)
Jinan Jinda Pharmaceutical Chemistry Co. Ltd. No. 6121 Longquan Road Zhangqiu, Shandong Province 250 20, China	No medically necessary products identified at this time Non-compliant rating issued No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Jost Chemicals Co. 8150 Lackland Rd. Saint Louis, Missouri, US	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Jubilant Generics Limited (Roorkee) Village Sikandarpur Bhainswal, Roorkee Dehradun Highway, Bhagwanpur, Roorkee District Haridwar, Uttarakhand, 247 661, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Jubilant Generics Limited (Roorkee) Village Sikandarpur Bhainswal, Roorkee Dehradun Highway, Bhagwanpur, Roorkee District Haridwar, Uttarakhand, India, 247 661 Inspection start date: 2021-03-02	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Keshava Organics Pvt. Ltd. T-97 & 100, MIDC-Tarapur Dist. Thane, Maharashtra 401506	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Kolmar Korea Co. Ltd. 245 Sandan-gil Jeonui-Myeon, Sejong-si Republic of Korea (South)	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Kopran Research Laboratories Limited K-4/4 Additional MIDC, At&Post Birwadi, Raigad District, Mahad, Maharashtra, India, 402302	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Kores (India) Limited (Plot Nos. 58/1, 58/2, 59A, 65A, 65B, 65C & 66A M.I.D.C. Industrial Area Dhatav, District Raigad, Roha, Maharashtra, India - 402 116)	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Kumar Organic Products Limited Plot No. 379, Maitri Marg, Canal Road, Luna, Taluk Padra, Vadodara, Gujarat, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Kyowa Hakko Bio Co., Ltd. 1-1 Kyowa-cho, Hofu-shi, Yamaguchi, Japan 747-8522.	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Kyowa Hakko Bio Co., Ltd. 1-1 Kyowa-cho, Hofu-shi, Yamaguchi, Yamaguchi, 747-8522, Japan Inspection start date: 2022-04-11	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Laboratoires Clarins 5 rue Ampére, Pontoise, 95300, France	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Lake Chemicals Pvt. Ltd. 21m, Attebele Industrial Area, Anekal Tauk, Bangalore, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. Industrial Park, Nankou; Gucheng, Lijiang, Yunnan CHINA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
LNK International Inc. 22 Arkay Drive, Hauppauge, NY, 11788, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
LNK International Inc. 40 Arkay Drive, Hauppauge, NY, 11788, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
LNK International Inc. 60 Arkay Drive, Hauppauge, NY, 11788, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
LNK International Inc. 100 Ricefield Lane, Hauppauge, NY, 11788, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
LNK International Inc. 145 Ricefield Lane, Hauppauge, NY, 11788, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP Observations
Lupin Limited Unit 2-Plot No. 2, SEZ Phase-II, Misc., Apparel Park, District Dhar, Pithampur, Indore, Madhya Pradesh, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Lupin Limited T-142, M.I.D.C. Tarapur, Via Boisar, Tal Palghar, Maharashtra, 401 506, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Lupin Limited Unit II Plot No. M-2 & M-2-A, Special Economic Zone Phase II, Misc. Zone, Apparel Park, Pithampur, Dist Dhar, Madhya Pradesh, 454775, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Mahendra Chemicals B-1, 217, 218/2, G.I.D.C. Estate, Naroda Ahmedabad, Gujarat India	Canadian importer(s) contacted by Health Canada for information. No medically necessary products identified Non-Compliant rating issued No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Malladi Drugs & Pharmaceuticals Ltd. Plot 67, 68, Sipcot Industrial Complex, Vellore, Ranipet, Tamil Nadu, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Marcus Research Laboratory Inc. 1820 Delmar Blvd, St. Louis, MO, 63103, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Marksans Pharma Limited Plot No. L-82, L-83, Verna Industrial Estate, Verna, Goa- India 403722	Canadian importer(s) contacted by Health Canada for information No medically necessary products identified at this time Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No Canadian importers (s) importing from this facility. No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Mefar Ilac Sanayii A.S. Ramazanoglu MahallesiEnsar Caddesi 20, Pendik, 34906, Turkey	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
MEGAFINE PHARMA (P) LIMITED 48 - 51/201 Plot No 31 - 35, Lakhamapur, Maharashtra INDIA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place for 6 importers Voluntary quarantine not accepted by 4 importers due to alternate risk mitigation measures being implemented by importer Health Canada on-site inspection [April 12, 2016] Health Canada inspection completed No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Megafine Pharma (P) Ltd. Plot No. 31 to 35 & 48 to 51, 5, 26 & K/201, Lakhmapur, Dindori (Taluka), Nashik (District), Maharashtra, 422202, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Megafine Pharma Ltd. 911 & 912, III Phase GIDC, Vapi, Gujarat, Maharashtra, India, 396195	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Meridian Medical Technologies 2555 Hermelin Dr., Brentwood, MO, 63144, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Micro Labs Bangalore Plots No. 113 to 116, 4th Phase, KIADB, Bommasandra Industrial Area, Jigani Link Road, Anekal Taluk, Bangalore, India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place Issued Terms and Conditions to Canadian importer(s) Related recalls and alerts: Health Canada takes action to restrict import of products from three Micro Labs facilities in India	Regulatory Partner(s)	General GMP observations
Micro Labs Goa Plot No. S-155 to S-159, Phase III, Verna Industrial Estate, Verna, Goa India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [September 19, 2016] No further action required by Health Canada at this time Related recalls and alerts: Health Canada takes action to restrict import of products from three Micro Labs facilities in India	Regulatory Partner(s)	Data integrity General GMP observations
Micro Labs Tamil Nadu 92 Sipcot Industrial Complex Hosur - Tamil Nadu, India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner). No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place Issued Terms and Conditions to Canadian importer(s) Related recalls and alerts: Health Canada takes action to restrict import of products from three Micro Labs facilities in India	Regulatory Partner(s)	Data integrity General GMP observations
Minsheng Group Shaoxing Pharmaceuticals Co. 315 Tanggong Road, Paojiand Industrial Zone. Shaoxing, Zhejiang, China 312071	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) Medically necessary products identified Requested voluntary quarantine Voluntary quarantine not accepted due to products being medically necessary No further action required by Health Canada at this time	Regulatory Partner(s) Canadian importer(s)	Data integrity General GMP observations
Mylan Laboratories Limited F-4 & F-12, Malegaon MIDC, inner, Nashik-422113 India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Mylan Laboratories Limited Unit 7, Plot No. 14, 99 & 100, IDA, Pashamylaram Phase II, Patancheru, Sangareddy District, Telangana, 502307, India.	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Mylan Laboratories Limited Unit 8, G. Chodavaram, POO Sapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535204, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Mylan Pharmaceuticals Inc. 781 Chestnut Ridge, Morgantown, West Virginia, USA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Neilmed Pharmaceuticals Inc 601 Aviation Blvd, Santa Rosa, CA, 95403, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Neilmed Pharmaceuticals Inc 601 Aviation Blvd, Santa Rosa, CA, 95403, United States NEW	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Nephron Pharmaceuticals Corporation 4500 12th Street Extension, West Columbia, SC, 29172, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Novacyl (Thailand) 321 Bangpoo Industrial Estate Praeska, Muang Sanutprakam, 10280 Thailand	Canadian importer(s) contacted by Health Canada for information No medically necessary products identified at this time No critical risks identified to date Compliant rating issued No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Novacyl Wuxi Pharmaceutical Co. Ltd. 8 Guang Shi Xi Road, Wuxi, Jiangsu, 214185, China	Canadian importer(s) contacted by Health Canada for information No medically necessary products identified at this time No critical risks identified to date Compliant rating issued No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Novel Laboratories, Inc. 400 Campus Drive, Somerset, NJ, 08873, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Noven Pharmaceuticals Inc. 11960 S.W. 144 Street - Miami, Florida, USA, 33186	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No critical risks identified to date No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
PAB Organics Private Limited 101-103, GIDC, Nandesari, Vadodara, Gujarat, 391340, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Panacea Biotec Limited Tehsil Nalagarh, Village Malpur, Baddi, District Solan, Himachal Pradesh	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
PCCA, Inc 9901 South Wilcrest, Houston, TX, 77099, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Pfizer Healthcare India Pvt. Ltd. Plot No. 111 (Part), 116, 117, 118, 119 and 123 (Part), Jawaharlal Nehru Pharma City, Special Economic Zone, Parawada Mandal, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Pharmaceutics International Inc. 103 Beaver Court, Cockeysville, MD, USA, 210303	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Pharmaceutics International Inc. 10819 Gilroy Rd, Hunt Valley, MD, USA, 21031	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued terms and conditions to Canadian importer(s)	Regulatory Partner(s)	General GMP observations
Pharmactive ilac San. ve Tic. A.S. Karaagag Mahallesi Fatih Bulvari, Kapakli, Tekirdag, 59510, Turkey	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Pharmasol Corporation 1 Norfolk Avenue, South Easton, Massachusetts, 02375, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Polydrug Laboratories Pvt. Ltd. Plot no. 37, Anand Nagar, M.I.D.C., India - 421 506 Ambernath (East), Maharashtra	No medically necessary products identified at this time Non-compliant rating issued No further action required by Health Canada at this time Related recalls and alerts: Health Canada requests quarantine of products imported for Canadian market from Polydrug Laboratories due to data integrity concerns	Regulatory Partner(s)	Data integrity General GMP observations
Professional Disposables International Inc. Two Nice-Pak Park, Orangeburg, NY, 10962-1376, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Qilu Tianhe Pharmaceutical Company Ltd. 849 Dongjia Town, Licheng District, Jinan City, Shandong, China, 250105	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Qinhuangdao Zizhu Pharmaceutical Co., Ltd No 10, Longhai Road, Economic & Technological Development Zon, Qinhuangdao, Hebei China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Recipharm Limited Vale of Bardsley, Ashton-Under-Lyne, OL7 9RR, United Kingdom	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Resonance Laboratories Private Limited No. 8C & 9A, K1ADB Industrial Area, Bashettihalli, Doddaballapur, Bangalore, India 561203	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Sage Products Inc. 3909 Three Oaks Road, Cary, Illinois, USA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Sancilio & Company Inc. 3874 Fiscal Ct Ste 200, Riviera Beach Florida, USA, 33404	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Sanochemia Pharmazeutika AG Landeggerstrasse 7 Neufeld an der Leitha 2941, Austria	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Sato Kogyo Co., Ltd 9-2, Kannonji-Cho, Kashihara City, Nara Prefecture, Japan	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
SC Johnson Professional Inc. (Formerly Deb USA Inc.) 1100 Highway 27 South Stanley, North Carolina 28164-2205, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Compliant rating issued	Regulatory Partner(s)	General GMP observations
Sekisui Medical Co., Ltd. 4-115 Matsuo, Hachimantai, Iwate Japan	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Sentiss Pharma Private Limited Village Khera Nihla, Tehsil Nalagarh, Dist: Solan Khera Nihla, Himachal Pradesh 174101, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Seven Star Pharmaceutical Co., Ltd No. 75, Fwu An Street, Tu Cheng District, New Taipei City, N/A, 23679, Taiwan	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Shandong Xinhua Pharmaceutical Co., Ltd Hutian Chemical Industrial Zone, Zibo, Shandong, 255075, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Shanghai Desano Chemical Pharmaceutical Co., Ltd. No.417 Binhai Road, Laogang Town, Pudong District, Shanghai, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Shilpa Medicare Limited Plot No. S-20 to S-26, Pharma SEZ, TSIIC, Green Industrial Park, Polepally Village, Jadcherla Mandal, Mahabubnagar District, Telangana, 509301, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Signa S.A. De C.V. 301 AV. Industria Automotriz, Zona Industrial Toluca, Toluca, Mexico, 50071, Mexico	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
SmithKline Beecham Limited Clarendon Road, Worthing, West Sussex, England, UK, BN14 8QH	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Solara Active Pharma Sciences Limited A1/B, SIPCOT Industrial Complex, Kudikadu Village, Cuddalore, Tamil Nadu, 607 005, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
SpecGX LLC 100 Louis Latzer Drive, Greenville, IL, USA, 62246	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Spectrum Laboratory Products, Inc. 14422 South San Pedro Street Gardena, California 90248, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Spectrum Laboratory Products, Inc. 769 Jersey Avenue New Brunswick, New Jersey 08901-3605, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Spectrum Chemical Mfg Corp. 755 and 769 Jersey Avenue, New Brunswick, NJ, 08901, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Sri Krishna Pharmaceuticals Ltd UNIT II A-35, IDA Nacharam Hyderabad 500 076 India	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Requested voluntary quarantine Voluntary quarantine in place Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [July 11, 2016] Terms and Conditions removed No further action required by Health Canada at this time Related recalls and alerts: Health products from Sri Krishna Pharmaceuticals quarantined due to data integrity concerns Release of medically necessary and non-medically necessary products according to terms and conditions	Regulatory Partner(s)	Data integrity General GMP observations
Srikem Laboratories Pvt. Ltd. Plot No. 17/24, MIDC Taloja, Navi Mumbai, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Stason Pharmaceuticals Inc. 11 Morgan, Irvine, CA, 92618, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Strides Pharma Science Limited Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Sun Pharmaceutical Industries Limited Halol Baroda Highway, Halol, Gujarat, 389 350, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Issued Terms and Conditions to Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Svizera Laboratories Private Limited Plot D-16/6 TTC Industrial Area, MIDC Turbhe, Navi Mumbai, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine Voluntary quarantine in place No Canadian importers (s) importing from this facility No further action required by Health Canada at this time	Regulatory Partner(s) Canadian importer(s)	Data Integrity General GMP observations
Symbiotec Pharmalab Pvt. Ltd. 385/2 Pigdamber, Near Hotel Mashal, Off A.B. Road, Rau, Indore, Madhya Pradesh, 453331, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Tai Heng Industry Co., Ltd., 2715 Long Wu Road, Building 2, Shanghai Juke Biotech Park, Shanghai, China 200231	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Takeda Pharmaceutical Company Limited 4720 Mitsui, Hikari, Yamaguchi, 743-8502, Japan	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Teligent Pharma US, LLC 105 Lincoln Avenue, Buena, NJ, 08310, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)	Regulatory Partner(s)	General GMP observations
Tender Corporation 944 Industrial Park Rd, Littleton, New Hampshire, 03561-3956, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd No 1889 Jingliu Road, Linjiang Industrial Zone, Zhejiang China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Torrent Pharmaceuticals Limited Ahmedabad-Mehsana Highway, Taluka-Kadi, Indrad, Gujarat	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Torrent Pharmaceuticals Limited Near Indrad Village, Taluka-Kadi Dist. Of Mehsana, Gujarat, 382721, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Toyobo Co Ltd 1-1 Katata 2-chom Otsu Pharmaceuticals Plant, Otsu-shi, Siga, 520-0292, Japan	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Trifarma S.P.A Via Pavese 2, Rozzano, N/A, 20089, Italy	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Tris Pharma Inc. 2033 Route 130, Monmouth Junction, NJ, 08852, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Ultra Seal Corporation 521 Main Street, New Paltz, USA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Ultratab Laboratories Inc., 50 Toc Drive, Highland, USA	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
UNIMARK REMEDIES LIMITED 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District 530 049, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Requested voluntary quarantine No Canadian importers (s) importing from this facility No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Unimark Remedies Limited (Vapi) Plot 41/42, Phase 1 - GIDC District Valsad Pardi, Gujarat, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Issued Terms and Conditions to Canadian importer(s) Removed Terms and Conditions from Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
UQUIFA-Union Farmaceutica S.A. Poligono Industrial El Pla.Avda.Puigcerda, 9 c-17 km 17.4, Llica de vall, Barcelona, 08185, Spain	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
US Pharmaceuticals, Inc. 681 Main Street, Building 27, Belleville, New Jersey	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No critical risks identified to date No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
USV Private Limited H-17/H-18, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data integrity General GMP observations
Vi-Jon LLC 8515 Page Avenue, St. Louis, MO, 63114-6014, United States	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Vital Laboratories Pvt Ltd (Plant I) 1416-21, 1507 1 and 2 Phase III GIDC, Vapi, 396195, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Vital Lab Private Limited Plant II Plot No.1710 & A1-2208, Phase III GIDC Estate, Vapi, Gujarat	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
VUAB PHARMA a.s Vltavska 53, Roztoky, CZECH REPUBLIC	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Issued Terms and Conditions to Canadian Importer(s)No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Wockhardt Limited Plot No. 138, G.I.D.C, Industrial Estate, District: Bharuch, Ankleshwar, Gujarat, 393002, India	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
Yicheng Goto Chemical Co.Ltd. 1 Group of Gaokeng, Xiaohe, Xiaohe, Yicheng, Hebei, 441003, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Yuki Gosei Kogyo Co. Ltd. 788 Ochiai, Joban Nishigo-Machi, Iwaki-Shi, Fukushima Japan, 972-8316	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
YUNNAN HANDE BIO-TECH. Co.Ltd No. 3 Platform Jinding Tech-Zone, Kunming, Yunnan Province, China	Canadian importer(s) contacted by Health Canada for information Medically necessary products identified No critical risks identified to date Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity General GMP observations
ZHEJIANG HISOAR PHARMACEUTICAL CO. LTD. No. 100 Waisha Branch Rd, Jiaojiang, Taizhou City, Zhejiang Province CN	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Requested voluntary quarantine of non-medically necessary products Voluntary quarantine in place No further action required by Health Canada at this time	Regulatory Partner(s)	Data Integrity
Zhejiang Hisun Pharma Company Ltd. 46 Waisha Road, Jiaojiang District,Taizhou City, Zhejiang, China Binhai Site - Yantou Campus 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, China	Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) Medically necessary products identified Requested voluntary quarantine Voluntary quarantine in place for 2 importers Voluntary quarantine not accepted by 1 importer due to alternate risk mitigation measures being implemented by importer Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [July 18, 2016] No further action required by Health Canada at this time Related recalls and alerts: Health Canada requests quarantine of products imported for Canadian market from Zhejiang Hisun Pharma due to data integrity concerns	Regulatory Partner(s) Canadian importer(s)	Data integrity General GMP observations
Zhejiang Hisun Pharmaceutical Co. Ltd 1 Haizheng Road, Jiaojiand District, Taizhou City, Zhejiang, 9999, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No medically necessary products identified at this time Health Canada on-site inspection [May 29, 2017] No further action required by Health Canada at this time	Regulatory Partner(s) Canadian importer(s)	Data integrity General GMP observations
Zhejiang Hisun Pharmaceutical Co., Ltd. 1 Haizheng Road, Jiaojiang District, Taizhou City, Zhejiang, 318 000, China Inspection start date: 2019-03-26	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Zhejiang Hisun Pharmaceutical Co., Ltd. 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, 318 000, China Inspection start date: 2019-03-26	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Zhejiang Huahai Pharmaceutical Co., Ltd 104 National Road, Xunqiao, Huahai Xunqiao Site, Linhai, Zhejiang, 317 024, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Zhejiang Huahai Pharmaceutical Co., Ltd. - Chuannan Site Coastal Industrial Zone, Duqiao, Linhai, Zhejiang, 317016, China	Canadian importer(s) contacted by Health Canada for information Health Canada has completed a GMP assessment and assessed the site as non-compliant Importers cannot import drugs that contain active pharmaceutical ingredients from this site Health Canada is continuing to review information as it becomes available. Issued terms and conditions to Canadian importer(s) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations
Zhejiang Medicine Co. Ltd Xinchang Pharmaceutical Factory, 98 East Xinchang Dadao Road, Xinchang, Zhejiang, 312500 China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s) Canadian importer(s)	Data integrity General GMP
Zhejiang Tianyu Pharmaceutical Co. Limited Jiangkou Development Zone, Huangyan District, Taizhou, Zhejiang, 318020, China	Canadian importer(s) contacted by Health Canada for information Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time	Regulatory Partner(s)	General GMP observations

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Date modified:: 2024-04-10

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Inspection tracker: Drug manufacturing establishments

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