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Drugs and Health Products

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: November 29, 2016.
 
Inspection Tracker: Drug Manufacturing Establishments
Establishment Status of Issue Source of Information under review Primary Reason for Action

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)
  • 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]
  • 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)
Regulatory Partner(s) 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]

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
  • 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 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]
  • Regulatory Partner(s)
  • Canadian importer(s)
  • Data integrity
  • 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
Interpharm Praha A.S. Komoranska 955, Praha, Modrany, Czech Republic
  • 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

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]

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]
  • 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]
  • 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

Micro Labs Goa
Plot No. S-155 to S-159, Phase III,
Verna Industrial Estate, Verna, 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]

Related recalls and alerts:

  • Regulatory Partner(s)
  • Data integrity
  • 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

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

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
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
  • 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]

Related recalls and alerts:

  • 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
  • Regulatory Partner(s)
  • Data integrity General GMP observations

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)
  • Regulatory Partner(s)
  • 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)
  • Regulatory Partner(s)
  • Data integrity
  • General GMP observations

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]
Related recalls and alerts:
  • Regulatory Partner(s)
  • Canadian importer(s)
  • Data Integrity
  • General GMP observations

Zhejiang Medicine Co. Ltd.
Xinchang Pharmaceutical Factory, Floor 3 Building A Kechuangyuan, 398 Mahuan Road, Binhaixincheng, Saoxing, Zhejiang, 212366, 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)
  • 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 issue
  • No further action required by Health Canada at this time

Related recalls and alerts:

  • Canadian importer(s)
  • Regulatory Partner(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
Anuh Pharma Ltd
E-17/3 and 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

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
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 informationNo 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

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

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
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
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

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

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
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

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

Sancilio & Company Inc.
3874 Fiscal Ct Ste 200, Riviera Beach Florida, 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
Shanghai DesanoChemical 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

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
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

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)
  • Regulatory Partner(s)
  • Data Integrity
  • 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