Inspection Tracker: Drug Manufacturing Establishments

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

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

• 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

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

• 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 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

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

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

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

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

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:

• 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

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

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

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

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
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

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 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

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

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

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

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

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

• 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

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

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

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:

• 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 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

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:

• 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

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

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

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

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

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

• 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

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

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