Inspection Tracker: Drug Manufacturing Establishments

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)

• Canadian importer(s) contacted by Health Canada for information
• Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)

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
• Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)

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)

Data Integrity

Lampugnani Farmaceutici SPA

• Canadian importer(s) contacted by Health Canada for information
• Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)

Yuki Gosei Kogyo Co. Ltd.
788 Ochiai, Joban Nishigo-Machi, Iwaki-Shi, Fukushima

• Canadian importer(s) contacted by Health Canada for information
• Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)

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)

Zhejiang Huahai Pharmaceutical Co., Ltd. - Chuannan Site

• Canadian importer(s) contacted by Health Canada for information
• Health Canada has completed a GMP assessment and assessed the site as non-compliant.
• Importers cannot import drugs that contain active pharmaceutical ingredients from this site.
• Health Canada is continuing to review information as it becomes available.  

• 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

• 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)

• 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

• 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)

• 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

• 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.

Data integrity

General GMP observations

• 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.

Data integrity

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

• 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)

Data integrity

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
• No further action required by Health Canada at this time

• 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

• 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

• 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

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

Data integrity

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 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

• 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

• 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

• 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)

• 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

• 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

Data integrity
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

• 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

• 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

Data Integrity

General GMP observations

• 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

Data Integrity

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 medically necessary products identified at this time
• No further action required by Health Canada at this time

Data Integrity

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 medically necessary products identified at this timeNo further action required by Health Canada at this time

Data Integrity

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

• 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

Data Integrity

General GMP observations

• 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

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

General GMP observations

Data Integrity

• 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

• 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

• 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

• 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

• 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

• 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

Data integrity

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

• 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

Data integrity

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 actions required by Health Canada at this time

• 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

Data integrity

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

• 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

• 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

• 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)

• 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

• 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

Data integrity

General GMP observations

• 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

Data integrity

General GMP observations

• 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

Data integrity

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 critical risks identified to date
• No further action required by Health Canada at this time

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

• No medically necessary products identified at this time Non-compliant rating issued
• No further action required by Health Canada at this time

Data integrity

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

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

• 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

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

• 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

• 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

• 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

Data integrity

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 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

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

• 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

• 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

Data integrity

General GMP observations

• 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

Data integrity

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
• 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

• 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

• 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

• 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

• 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

• 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

• 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 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

Data integrity

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

• 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

• 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

• 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

Data integrity

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

• 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

Data integrity

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 medically necessary products identified at this time
• No further action required by Health Canada at this time

Data integrity

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 medically necessary products identified at this time
• No further action required by Health Canada at this time

• 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

Data integrity

General GMP observations

• 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

Data integrity

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 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

Data Integrity

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

Data integrity

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

• 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

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

• 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

Data integrity

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

• 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

Data Integrity

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

Data Integrity

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

• 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

Data Integrity

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
• Requested voluntary quarantine of non-medically necessary products
• Voluntary quarantine in place
• No further action required by Health Canada at this time

• Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
• Medically necessary products identified
• Requested voluntary quarantine
• Voluntary quarantine in place for 2 importers
• Voluntary quarantine not accepted by 1 importer due to alternate risk mitigation measures being implemented by importer Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [July 18, 2016]
• No further action required by Health Canada at this time

Related recalls and alerts:

• Health Canada requests quarantine of products imported for Canadian market from Zhejiang Hisun Pharma due to data integrity concerns

• Regulatory Partner(s)
• Canadian importer(s)

Data integrity

General GMP observations

• 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

• 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