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 & 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 18, 2018.
Open Items
Establishment Status of Issue Source of Information under Review Primary Reason for Action
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)
 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)
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)
 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)
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)
 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
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
  • Regulatory Partner(s)
  • Canadian importer(s)
  • Data integrity
  • General GMP observations
Closed Items
Establishment Status of Issue Source of Information under Review Primary Reason for Action
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
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:
  • 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
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, 4th Phase, Jigani Link Road, Bangalore, Karnataka, India

Related recalls and alerts:

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

Related recalls and alerts:

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
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
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
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

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
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
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
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
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
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:

 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
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
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)
  • 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

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
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
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
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:

 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
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 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
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.
 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:

 Regulatory Partner(s)

Data integrity

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
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
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

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
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
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
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

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:

 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:

 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:

 Regulatory Partner(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
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
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
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
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:

 Regulatory Partner(s)

Data integrity

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
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
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
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
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
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
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
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:

 Regulatory Partner(s)

Data integrity

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
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
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
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
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
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
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:
  • 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 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 observations
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