3/21/2018 Inspection Tracker: Drug Manufacturing Establishments - Canada.ca
Home Health Canada Drugs and Health Products Reports and Publications – Drugs and Health Products Compliance and Enforcement 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: March 20, 2018.
Open Items
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Source of Information Primary under Reason for Establishment Status of Issue Review Action
Antibioticos do Brasil Canadian importer(s) contacted Regulatory General Rod. Professor Zeferino Vaz, Km135- by Health Canada for information Partner(s) GMP SP332, Cosmopolis, Sao Paulo, Brazil observations Continuing to review evidence 13150-000 submitted (i.e corrective actions, information from regulatory partner)
Medically necessary products identified
Issued terms and conditions to Canadian importer(s)
Apotex Research Private Limited Canadian importer(s) contacted Regulatory General (ARPL) by Health Canada for information Partner(s) GMP Plot No. 1 and No. 2, Bommasandra Continuing to review evidence observations Industrial Area, 4th Phase, Jigani Link submitted (i.e corrective actions, Road, Bangalore, India information from regulatory partner) No further action required by Health Canada at this time
Bayer S.A Canadian importer(s) contacted Regulatory Data Km 14.5 Calzada Roosevelt, Zona 3 De by Health Canada for information Partner(s) Integrity Mixco, Medically necessary products General Guatemala, N/A, 1901, Guatemala identified GMP observations Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
Issued terms and conditions to Canadian importer(s)
Beauty Manufacturing Solutions Corp. Canadian importer(s) contacted Regulatory General 1250 Freeport Parkway, Coppell, Texas by Health Canada for information Partner(s) GMP Continuing to review evidence observations submitted (i.e corrective actions, information from regulatory partner)
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Source of Information Primary under Reason for Establishment Status of Issue Review Action
Celltrion, Inc. Canadian importer(s) contacted Regulatory General 23 Academy-ro, Yeonsu-gu, Incheon, by Health Canada for information Partner(s) GMP 22014 Republic of Korea Continuing to review evidence observations submitted (i.e corrective actions, information from regulatory partner)
Continental Manufacturing Chemist, Canadian importer(s) contacted Regulatory General Inc. by Health Canada for information Partner(s) GMP 912 S. State St., Madrid, Iowa observations Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
Cheng Fong Chemical Co. Ltd. No. 19, Canadian importer(s) contacted Regulatory General Gong 4th Road, Dayuan district, Taoyuan by Health Canada for information Partner(s) GMP City 337, Taiwan observations Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
Issued terms and conditions to Canadian importer(s)
Interpharm Praha A.S. Canadian importer(s) contacted Regulatory General Komoranska 955, Praha, Modrany by Health Canada for information Partner(s) GMP observations Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
Issued Terms and Conditions to Canadian importer(s)
Jilin Shulan Synthetic Pharmaceutical Canadian importer(s) Regulatory Co. Ltd. contacted by Health Canada Partner(s) No. 2066 Peoples Main Road, Shulan, for information Jilin - China Foreign building refused to provide GMP evidence to Importer or Health Canada for assessment
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Source of Information Primary under Reason for Establishment Status of Issue Review Action
Lijiang Yinghua Biochemical and Canadian importer(s) contacted Regulatory General Pharmaceutical Co., Ltd. by Health Canada for information Partner(s) GMP Industrial Park , Nankou; Gucheng , Continuing to review evidence observations Lijiang, Yunnan CHINA submitted (i.e. corrective actions, information from regulatory partner)
Lupin Limited Canadian importer(s) contacted Regulatory General Unit 2-Plot No. 2, SEZ Phase-II, by Health Canada for information Partner(s) GMP Misc., Apparel Park, Continuing to review evidence observations District Dhar, submitted (i.e. corrective actions, Pithampur, Indore, information from regulatory Madhya Pradesh, partner) India
Malladi Drugs & Pharmaceuticals Ltd. Canadian importer(s) contacted Regulatory General Plot 67, 68, Sipcot Industrial Complex, by Health Canada for information Partner(s) GMP Vellore, Ranipet, Tamil Nadu, India observations Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
No further action required by Health Canada at this time
Micro Labs Tamil Nadu Continuing to review evidence Regulatory Data 92 Sipcot Industrial Complex submitted (i.e corrective actions, Partner(s) integrity Hosur - Tamil Nadu, India information from regulatory General partner). GMP No medically necessary products observations 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
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Source of Information Primary under Reason for Establishment Status of Issue Review Action
Micro Labs Bangalore Continuing to review evidence Regulatory General Plots No. 113 to 116, 4th Phase, KIADB, submitted (i.e corrective actions, Partner(s) GMP Bommasandra Industrial Area, Jigani information from regulatory observations Link Road, Anekal Taluk, Bangalore, partner) India 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
Minsheng Group Shaoxing Canadian importer(s) contacted Regulatory Data Pharmaceuticals Co. by Health Canada for information Partner(s) integrity 315 Tanggong Road, Paojiand Industrial Continuing to review evidence Canadian General Zone. Shaoxing, Zhejiang, China 312071 submitted (i.e. corrective actions, importer(s) GMP information from regulatory observations partner)
Medically necessary products identified
Requested voluntary quarantine
Voluntary quarantine not accepted due to products being medically necessary
Pharmaceutics International Inc. 10819 Canadian importer(s) contacted Regulatory General Gilroy Rd, Hunt Valley, MD, USA, 21031 by Health Canada for information Partner(s) GMP observations 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)
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Source of Information Primary under Reason for Establishment Status of Issue Review Action
Vital Lab Private Limited Plant II Canadian importer(s) contacted Regulatory General Plot No.1710 & A1-2208, Phase III GIDC by Health Canada for information Partner(s) GMP Estate, Vapi, Gujarat Continuing to review evidence observations submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time
Yicheng Goto Chemical Co.Ltd. Canadian importer(s) contacted Regulatory General 1 Group of Gaokeng, Xiaohe, Xiaohe, by Health Canada for information Partner(s) GMP Yicheng, Hebei, 441003, China Continuing to review evidence observations submitted (i.e corrective actions, information from regulatory partner) No further action required by Health Canada at this time
Closed Items
Source of Information Primary under Reason Establishment Status of Issue Review for Action
AGILA SPECIALTIES Canadian importer(s) contacted by Health Regulatory General PRIVATE LTD., Canada for information Partner(s) GMP SPECIALTY observations Continuing to review evidence submitted (i.e FORMULATION corrective actions, information from regulatory FACILITY (SFF) partner) 19A, Plot No. 284-B/1 Bommasandra Jigani Medically necessary products identified Link Road, Anekal Requested voluntary quarantine of non-medically Taluk, Bangalore India - necessary products 560 105 Voluntary quarantine in place
Issued terms and conditions to Canadian importer(s)
No further action required by Health Canada at this time
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement/inspection-tracker-drug-manuf… 6/31 3/21/2018 Inspection Tracker: Drug Manufacturing Establishments - Canada.ca
Source of Information Primary under Reason Establishment Status of Issue Review for Action
Agila Onco Therapies Non-compliant rating issued Regulatory General Ltd. Partner(s) GMP No further action required by Health Canada at Plot No. 284/B observations this time Canadian Bommasandra Jigani importer(s) Link Road, Industrial Related recalls and alerts: Area, Bangalore, Kamataka, India Methotrexate Injection USP 50 mg/2 mL - Voluntary Recall Due to the Potential Presence of Foreign Particulate Matter
AGILA SPECIALTIES Canadian importer(s) contacted by Health Regulatory General PRIVATE LTD. Canada for information Partner(s) GMP Opp II M, Bilekahalli, observations No critical risks identified to date Bannerghatta Road, Bangalore, Karnataka, No further action required by Health Canada at India - 560 076 this time
Anuh Pharma Ltd Canadian importer(s) contacted by Health Regulatory General E-17/3 & E 17/4 Canada for information Partner(s) GMP M.I.D.C. Tarapur, Taluka observations Continuing to review evidence submitted (i.e Palghar, District Thane, corrective actions, information from regulatory India-401 506 Boisar, partner) Maharashtra No medically necessary products identified at this time
No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Apotex Pharmachem Requested stop sale Health Data India Private Limited Canada integrity Import restrictions imposed (APIPL) Regulatory General Plot No. 1A, On September 30, 2014, Issued Terms and Partner(s) GMP Bommasandra Industrial Conditions to Canadian importer(s) observations Area, 4th Phase, Jigani Continuing to review evidence submitted (i.e Link Road, Bangalore, corrective actions, information from regulatory Karnataka, India 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.
Apotex Research Voluntary quarantine was in place until further Health Data Private Limited (ARPL) assessment was completed Canada integrity Plot No. 1 and No. 2, Import restrictions imposed https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement/inspection-tracker-drug-manuf… 8/31 3/21/2018 Inspection Tracker: Drug Manufacturing Establishments - Canada.ca Bommasandra Industrial Regulatory General Source of Area, 4th Phase, Jigani Partner(s) GMP Link Road, Bangalore, Information oPrimarybservations India under Reason Establishment Status of Issue Review for Action 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. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement/inspection-tracker-drug-manuf… 9/31 3/21/2018 Inspection Tracker: Drug Manufacturing Establishments - Canada.ca
Source of Information Primary under Reason Establishment Status of Issue Review for Action
B. Braun Medical Inc. Canadian importer(s) contacted by Health Regulatory General 2525 McGaw Avenue Canada for information Partner(s) GMP Irvine, CA, 92614-5895 observations Continuing to review evidence submitted (i.e United States corrective actions, information from regulatory partner)
Medically necessary products identified
No further action required by Health Canada at this time
Biocon Limited, Works Canadian importer(s) contacted by Health Regulatory Data Unit II Canada for information Partner(s) integrity Plot Nos 2-4, Phase IV, Continuing to review evidence submitted (i.e General Bommasandra-Jigani corrective actions, information from regulatory GMP Link Road partner) observations Bangalore, Karnataka India 560099 No medically necessary products identified
No further action required by Health Canada at this time
Beijing Taiyang Canadian importer(s) contacted by Health Regulatory Data Pharmaceutical Canada for information Partner(s) Integrity Industry Co Ltd Continuing to review evidence submitted (i.e No. 1 Shuangqiao (E) corrective actions, information from regulatory Road, Chaoyang, partner) Beijing China No medically necessary products identified at this time
No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Bend Research Inc Canadian importer(s) contacted by Health Regulatory Data 20503 Builders Street, Canada for information Partner(s) Integrity Bend, Oregon, USA, Continuing to review evidence submitted (i.e General 97701 corrective actions, information from regulatory GMP partner) observations 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
Cadila Canadian importer(s) contacted by Health Regulatory General Pharmaceuticals Canada for information Partner(s) GMP Limited. observations Continuing to review evidence submitted (i.e 294, G.I.D.C. Industrial corrective actions, information from regulatory Estate, Ankleshwar, partner) India 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
ChemRite CoPac Inc. Canadian importer(s) contacted by Health Regulatory General 19725 W. Edgewood Canada for information Partner(s) GMP Dr., Lannon, WI, USA Continuing to review evidence submitted (i.e observations corrective actions, information from regulatory partner) No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Chongqing Pharma Canadian importer(s) contacted by Health Regulatory Data Research Institute Co., Canada for information Partner(s) Integrity Ltd. Continuing to review evidence submitted (i.e No. 565 Tushan Road, corrective actions, information from regulatory Nanan partner) District, Chongqing, No further action required by Health Canada at China this time
Concord Biotech Canadian importer(s) contacted by Health Regulatory General Limited Canada for information Partner(s) GMP 1482-1486 Trasad observations Continuing to review evidence submitted (i.e Road, Dholka corrective actions, information from regulatory Ahmedabad, Gujarat partner) 387810, India No further action required by Health Canada at this time
CTX Life Sciences Pvt. Canadian importer(s) contacted by Health Regulatory General Ltd. Canada for information Partner(s) GMP 251-252 Sachin- observations Continuing to review evidence submitted (i.e Magdalla Road, G.I.D.C, corrective actions, information from regulatory Sachin, Surat, Gujarat, partner) India, 394230 No further action required by Health Canada at this time
Divi's Laboratories Canadian importer(s) contacted by Health Regulatory Data Ltd. Canada for information Partner(s) Integrity Unit 2, Chippada Continuing to review evidence submitted (i.e General Village, corrective actions, information from regulatory GMP Bheemunipatnam, partner) observations Visakhapatnam, Andhra Pradesh, 531 162, India 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
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement/inspection-tracker-drug-manu… 12/31 3/21/2018 Inspection Tracker: Drug Manufacturing Establishments - Canada.ca
Source of Information Primary under Reason Establishment Status of Issue Review for Action
Dr. Reddy's Continuing to review evidence submitted (i.e Regulatory Data Laboratories corrective actions, information from regulatory Partner(s) Integrity APIIC Ind. Est, Unit VI partner)No medically necessary products General Pydibhimavarma identified at this time GMP (Village) Ranasthalam Requested voluntary quarantine observations Mandal, Srikakulam District, India 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
Dr. Reddy's Canadian importer(s) contacted by Health Regulatory Data Laboratories Canada for information Partner(s) Integrity Unit V Peddadevulapalli, Continuing to review evidence submitted (i.e General Tripuraram Mandal, corrective actions, information from regulatory GMP Nalgonad District, partner) observations Andhra Pradesh No medically necessary products identified at this time
No further action required by Health Canada at this time
Dr. Reddy's Canadian importer(s) contacted by Health Regulatory Data Laboratories Canada for information Partner(s) Integrity Unit VII Plot No. P1 to Continuing to review evidence submitted (i.e General P9, Phase III, Duvvada, corrective actions, information from regulatory GMP VSEZ, Visakhapatnam, partner) observations Andhra Pradesh IN No medically necessary products identified at this timeNo further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Emcure Canadian importer(s) contacted by Health Regulatory Data Pharmaceuticals Canada for information Partner(s) Integrity Limited Canadian Continuing to review evidence submitted (i.e. General Plot No. P-1 & P-2,, IT- importer(s) corrective actions, information from regulatory GMP BT Park Phase II, partner) observations MIDC, Hinjwadi, Hinjwadi, Pune, Medically necessary products identified Health Maharashtra INDIA Canada on-site inspection [June 14, 2016]
No further action required by Health Canada at this time
EVERLIGHT Canadian importer(s) contacted by Health Regulatory Data CHEMICALS Canada for information Partner(s) Integrity INDUSTRIAL No medically necessary products identified at this CORPORATION time 12, Industrial Third Rd, Kuanyin Industrial Health Canada on-site inspection (November 9- District, Kuanyin Hsiang, 13) Taoyuan Hsien, 32853, Non-Compliant rating issued Taiwan No further action required by Health Canada at this time
Evertogen Life Canadian importer(s) contacted by Health Regulatory General Sciences Limited Canada for information Partner(s) GMP PLOT NO: S-8, S-9, S- observations Continuing to review evidence submitted (i.e 13/P & S-14/P TSIIC, corrective actions, information from regulatory Data Pharma Sez partner) Integrity Green Industrial Park, Polepally (V), No further action required by Health Canada at Jadcherla (M), this time Mahabubnagar, Telangana, IN-509 301, India
Granules India Limited Canadian importer(s) contacted by Health Regulatory General Plot No. 160/A, 161/E, Canada for information Partner(s GMP 162 & 174/A, Gagillapur observations Continuing to review evidence submitted (i.e Village, Qutbullapur corrective actions, information from regulatory Mandal, Ranga Reddy partner) District, Telangana state, Hyderabad, No further action required by Health Canada at 500043, India this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
HEBEI YUXING BIO- Canadian importer(s) contacted by Health Regulatory Data ENGINEEERING CO. Canada for information Partner(s) Integrity LIMITED Continuing to review evidence submitted (i.e Xicheng District, Ningjin corrective actions, information from regulatory county, Ningjin, Heibei partner) China 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
Hetero Labs Limited Canadian importer(s) contacted by Health Regulatory General Unit V Sy.No.439-441, Canada for information Partner(s) GMP 458 TSIIC Formulation observations Continuing to review evidence submitted (i.e SEZ corrective actions, information from regulatory Polepally Village, partner) Jadcherla Mandal Mahaboobnagar, No further action required by Health Canada at Telangana this time India 509301
Hospira Inc. Canadian importer(s) contacted by Health Regulatory General 1776 North Centennial Canada for information Partner(s) GMP Drive, McPherson, KS, observations Continuing to review evidence submitted (i.e United States, 67460- corrective actions, information from regulatory 9301 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Hubei Hongyuan Canadian importer(s) contacted by Health Regulatory General Pharmaceutical Canada for information Partner(s) GMP Technology Co. Ltd. observations Continuing to review evidence submitted (i.e No. 428 Yishui North corrective actions, information from regulatory Road, Luotian County, partner) Huanggang City, China- 438 600, Fengshan No further action required by Health Canada at Town, Hubei Province this time
Hubei Hongyuan Canadian importer(s) contacted by Health Regulatory Data Pharmaceutical Canada for information Partner(s) integrity Technology Co. Ltd. Continuing to review evidence submitted (i.e General No.8 Fengshan Road, corrective actions, information from regulatory GMP Industrial and Economic partner) observations Development Zone, Luotian County, China No further action required by Health Canada at 438 600, Huanggang this time City, Hubei Province
Ind-Swift Laboratories Canadian importer(s) contacted by Health Regulatory Data Limited Canada for information Partner(s) integrity Barwala Road, Continuing to review evidence submitted (i.e General Bhagwanpur Village - corrective actions, information from regulatory GMP Derabassi District partner) observations Mohali, 140 507 Punjab, India No critical risks identified to date
No further action required by Health Canada at this time
Indoco Remedies Canadian importer(s) contacted by Health Regulatory General Limited Canada for information Partner(s) GMP Plants II & III, L-32, 33, Continuing to review evidence submitted (i.e. observations 34 Verna Industrial corrective actions, information from regulatory Estate Area, Verna, partner) Goa, India No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Intas Pharmaceuticals Canadian importer(s) contacted by Health Regulatory General Limited (IPL) Canada for information Partner(s) GMP Plot No. 423 / P / A Continuing to review evidence submitted (i.e observations Sarkhej – Bavla corrective actions, information from regulatory Highway Village partner) Moraiya, Taluka Sanand No further action required by Health Canada at Ahmedabad – 382213 this time Gujarat, India
INTERQUIM, S.A., Canadian importer(s) contacted by Health Regulatory General C/ Joan Buscalla, 10 Canada for information Partner(s) GMP Sant Cugat del Valles observations Continuing to review evidence submitted (i.e. Barcelona, Spain 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
IPCA Laboratories Ltd. Continuing to review evidence submitted (i.e Regulatory Data P.O. Box No. 33 Village corrective actions, information from regulatory Partner(s) integrity Sejavta Ratlam, Madya partner) General Pradesh, India Medically necessary products identified GMP observations 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
IPCA Laboratories Ltd Continuing to review evidence submitted (i.e Regulatory Data Plot 65 & 99, corrective actions, information from regulatory Partner(s) integrity Dandudyog Industrial partner) General Estate, Piparia, Terms and Conditions for IPCA Ratlam apply to GMP Silvassa, Dadra & the Piparia products. observations Nagar Haveli (U.T.), 396 230, India Health Canada on-site inspection [August 19, 2016]
No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
IPCA Laboratories Ltd. Continuing to review evidence submitted (i.e Regulatory Data 1 Pharma Zone, SEZ corrective actions, information from regulatory Partner(s) integrity Phase II, Sector 3, partner) General District Dhar, Pithampur, No medically necessary products identified at this GMP India time observations 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
Jiangxi Synergy Canadian importer(s) contacted by Health Regulatory General Pharmaceutical Co., Canada for information Partner(s) GMP Ltd. observations Continuing to review evidence submitted (i.e Jiangxi Fengxin corrective actions, information from regulatory Industrial Park, China- partner) 330 700, Fengxin, Jiangxi Province No critical risks identified to date
No further action required by Health Canada at this time
Jinan Jinda No medically necessary products identified at this Regulatory Data Pharmaceutical time Non-compliant rating issued Partner(s) integrity Chemistry Co. Ltd. No further action required by Health Canada at General No. 6121 Longquan this time GMP Road observations Zhangqiu, Shandong Province 250 20, China
Kores (India) Limited Canadian importer(s) contacted by Health Regulatory General Canada for information Partner(s) GMP (Plot Nos. 58/1, 58/2, observations 59A, 65A, 65B, 65C & Continuing to review evidence submitted (i.e. 66A M.I.D.C. Industrial corrective actions, information from regulatory Area Dhatav, District partner) Raigad, Roha, No further action required by Health Canada at Maharashtra, India - 402 this time 116)
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Mahendra Chemicals Canadian importer(s) contacted by Health Regulatory Data B-1, 217, 218/2, Canada for information. Partner(s) Integrity G.I.D.C. Estate, Naroda No medically necessary products identified Ahmedabad, Gujarat India Non-Compliant rating issued
No further action required by Health Canada at this time
Marksans Pharma Canadian importer(s) contacted by Health Regulatory Data Limited Canada for information Partner(s) integrity Plot No. L-82, L-83, No medically necessary products identified at this General Verna Industrial Estate, time GMP Verna, Goa- India observations 403722 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
MEGAFINE PHARMA Canadian importer(s) contacted by Health Regulatory Data (P) LIMITED Canada for information Partner(s) Integrity 48 - 51/201 Plot No 31 - Continuing to review evidence submitted (i.e 35, Lakhamapur, corrective actions, information from regulatory Maharashtra INDIA 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Meridian Medical Canadian importer(s) contacted by Health Regulatory General Technologies Canada for information Partner(s) GMP 2555 Hermelin Dr., Continuing to review evidence submitted (i.e observations Brentwood, MO, 63144, corrective actions, information from regulatory United States partner) Medically necessary products identified No further action required by Health Canada at this time
Micro Labs Goa Continuing to review evidence submitted (i.e Regulatory Data Plot No. S-155 to S-159, corrective actions, information from regulatory Partner(s) integrity Phase III, partner) General Verna Industrial Estate, No medically necessary products identified at this GMP Verna, Goa India time observations 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
Mylan Laboratories Canadian importer(s) contacted by Health Regulatory General Limited Canada for information Partner(s) GMP F-4 & F-12, Malegaon observations Continuing to review evidence submitted (i.e MIDC, corrective actions, information from regulatory inner, Nashik-422113 partner) India No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Novacyl (Thailand) Canadian importer(s) contacted by Health Regulatory General 321 Bangpoo Industrial Canada for information Partner(s) GMP Estate observations No medically necessary products identified at this Praeska, Muang time Sanutprakam, 10280 Thailand No critical risks identified to date
Compliant rating issued
No further action required by Health Canada at this time
Novacyl Wuxi Canadian importer(s) contacted by Health Regulatory General Pharmaceutical Co. Canada for information No medically necessary Partner(s) GMP Ltd. products identified at this time observations 8 Guang Shi Xi Road, No critical risks identified to date Wuxi, Jiangsu, 214185, China Compliant rating issued
No further action required by Health Canada at this time
Noven Canadian importer(s) contacted by Health Regulatory General Pharmaceuticals Inc. Canada for information Partner(s) GMP 11960 S.W. 144 Street - observations Continuing to review evidence submitted (i.e Miami, Florida, USA, corrective actions, information from regulatory 33186 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Pharmaceutics Canadian importer(s) contacted by Health Regulatory General International Inc. Canada for information Partner(s) GMP 103 Beaver Court, observations Continuing to review evidence submitted (i.e Cockeysville, MD, USA, corrective actions, information from regulatory 210303 partner)
No medically necessary products identified at this time
No further action required by Health Canada at this time
Polydrug Laboratories No medically necessary products identified at this Regulatory Data Pvt. Ltd. time Partner(s) integrity Plot no. 37, Anand Non-compliant rating issued General Nagar, M.I.D.C., India - GMP 421 506 Ambernath No further action required by Health Canada at observations (East), Maharashtra this time
Related recalls and alerts:
Health Canada requests quarantine of products imported for Canadian market from Polydrug Laboratories due to data integrity concerns
Qinhuangdao Zizhu Canadian importer(s) contacted by Health Regulatory General Pharmaceutical Co., Canada for information Partner(s) GMP Ltd observations Continuing to review evidence submitted (i.e No 10, Longhai Road, corrective actions, information from regulatory Economic & partner) Technological Development Zon, No further action required by Health Canada at Qinhuangdao, Hebei this time China
Resonance Canadian importer(s) contacted by Health Regulatory General Laboratories Private Canada for information Partner(s) GMP Limited observations Continuing to review evidence submitted (i.e No. 8C & 9A, K1ADB corrective actions, information from regulatory Industrial partner) Area, Bashettihalli, Doddaballapur, No further action required by Health Canada at Bangalore, India 561203 this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Sage Products Inc. Canadian importer(s) contacted by Health Regulatory General 3909 Three Oaks Road, Canada for information Partner(s) GMP Cary, Illinois, USA Continuing to review evidence submitted (i.e observations corrective actions, information from regulatory partner) No further action required by Health Canada at this time
Sancilio & Company Canadian importer(s) contacted by Health Regulatory Data Inc. Canada for information Partner(s) integrity 3874 Fiscal Ct Ste 200, Continuing to review evidence submitted (i.e General Riviera Beach Florida, corrective actions, information from regulatory GMP USA, 33404 partner) observations No medically necessary products identified at this time
No further action required by Health Canada at this time
Sato Kogyo Co., Ltd Canadian importer(s) contacted by Health Regulatory General 9-2, Kannonji-Cho, Canada for information Partner(s) GMP Kashihara City, Nara observations Continuing to review evidence submitted (i.e Prefecture, Japan corrective actions, information from regulatory partner)
No further action required by Health Canada at this time
Sekisui Medical Co., Canadian importer(s) contacted by Health Regulatory Data Ltd. Canada for information Partner(s) integrity 4-115 Matsuo, Continuing to review evidence submitted (i.e General Hachimantai, Iwate corrective actions, information from regulatory GMP Japan partner) observations No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Shanghai Desano Canadian importer(s) contacted by Health Regulatory Data Chemical Canada for information Partner(s) integrity Pharmaceutical Co., Continuing to review evidence submitted (i.e General Ltd. corrective actions, information from regulatory GMP No.417 Binhai Road, partner) observations Laogang Town, Pudong District, Shanghai, No medically necessary products identified at this China time
No further action required by Health Canada at this time
Sri Krishna Continuing to review evidence submitted (i.e Regulatory Data Pharmaceuticals Ltd corrective actions, information from regulatory Partner(s) integrity UNIT II A-35, IDA partner) General Nacharam Medically necessary products identified GMP Hyderabad 500 076 observations India 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
https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement/inspection-tracker-drug-manu… 25/31 3/21/2018 Inspection Tracker: Drug Manufacturing Establishments - Canada.ca
Source of Information Primary under Reason Establishment Status of Issue Review for Action
SmithKline Beecham Canadian importer(s) contacted by Health Regulatory General Limited Canada for information Partner(s) GMP Clarendon Road, observations Continuing to review evidence submitted (i.e Worthing, West Sussex, corrective actions, information from regulatory England, UK, BN14 partner) 8QH No medically necessary products identified at this time
No further action required by Health Canada at this time
Srikem Laboratories Canadian importer(s) contacted by Health Regulatory Data Pvt. Ltd. Plot No. 17/24, Canada for information Partner(s) integrity MIDC Taloja, Navi Continuing to review evidence submitted (i.e General Mumbai, India corrective actions, information from regulatory GMP partner) observations No medically necessary products identified at this time
No further action required by Health Canada at this time
Svizera Laboratories Canadian importer(s) contacted by Health Regulatory Data Private Limited Canada for information Partner(s) Integrity Plot D-16/6 TTC Canadian Continuing to review evidence submitted (i.e General Industrial Area, importer(s) corrective actions, information from regulatory GMP MIDC partner) observations Turbhe, Navi Mumbai, India 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Tai Heng Industry Co., Canadian importer(s) contacted by Health Regulatory Data Ltd., Canada for information Partner(s) integrity 2715 Long Wu Road, Continuing to review evidence submitted (i.e General Building 2, Shanghai corrective actions, information from regulatory GMP Juke Biotech Park, partner) observations Shanghai, China 200231 No further action required by Health Canada at this time
Teva Pharmaceutical Canadian importer(s) contacted by Health Regulatory General and Chemical Canada for information Partner(s) GMP (Hangzhou) Co. Ltd No observations Continuing to review evidence submitted (i.e 1889 Jingliu Road, corrective actions, information from regulatory Linjiang Industrial Zone, partner) Zhejiang China No further action required by Health Canada at this time
UNIMARK REMEDIES Canadian importer(s) contacted by Health Regulatory Data LIMITED Canada for information Partner(s) Integrity 337 Kerala Nalsarovar Continuing to review evidence submitted (i.e Road, Kerala Village, corrective actions, information from regulatory Bavla, Ahmedabad partner) District 530 049, India 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Unimark Remedies Canadian importer(s) contacted by Health Regulatory General Limited (Vapi) Canada for information Partner(s) GMP Plot observations Continuing to review evidence submitted (i.e 41/42, Phase 1 – GIDC corrective actions, information from regulatory District Valsad Pardi, partner) Gujarat, India 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
USV Private Limited Canadian importer(s) contacted by Health Regulatory Data H-17/H-18, OIDC, Canada for information Partner(s) integrity Mahatma Gandhi Udyog Continuing to review evidence submitted (i.e General Nagar, Dabhel, Daman corrective actions, information from regulatory GMP partner) observations No further action required by Health Canada at this time
VUAB PHARMA a.s Canadian importer(s) contacted by Health Regulatory Data Vltavska 53, Roztoky, Canada for information Partner(s) Integrity CZECH REPUBLIC Continuing to review evidence submitted (i.e General corrective actions, information from regulatory GMP partner) observations 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
Wockhardt Limited Canadian importer(s) contacted by Health Regulatory Data Plot No. 138, G.I.D.C, Canada for information Partner(s) Integrity Industrial Estate, Continuing to review evidence submitted (i.e General District: Bharuch, corrective actions, information from regulatory GMP Ankleshwar, Gujarat, partner) observations 393002, India No further action required by Health Canada at this time
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
YUNNAN HANDE BIO- Canadian importer(s) contacted by Health Regulatory Data TECH. Co.Ltd Canada for information Partner(s) Integrity No. 3 Platform Jinding Medically necessary products identified General Tech-Zone, Kunming, GMP Yunnan Province, China No critical risks identified to date observations Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
No further action required by Health Canada at this time
ZHEJIANG HISOAR Canadian importer(s) contacted by Health Regulatory Data PHARMACEUTICAL Canada for information Partner(s) Integrity CO. LTD. Continuing to review evidence submitted (i.e No. 100 Waisha Branch corrective actions, information from regulatory Rd, Jiaojiang, Taizhou partner) City, Zhejiang Province CN 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
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Source of Information Primary under Reason Establishment Status of Issue Review for Action
Zhejiang Hisun Continuing to review evidence submitted (i.e Regulatory Data Pharma Company Ltd. corrective actions, information from regulatory Partner(s) integrity 46 Waisha Road, partner) Canadian General Jiaojiang Medically necessary products identified importer(s) GMP District,Taizhou City, observations Zhejiang, China Binhai Requested voluntary quarantine Site - Yantou Campus Voluntary quarantine in place for 2 importers 56 Binhai Road, Jiaojiang District, Voluntary quarantine not accepted by 1 importer Taizhou City, due to alternate risk mitigation measures being Zhejiang, China 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
Zhejiang Hisun Canadian importer(s) contacted by Health Regulatory Data Pharmaceutical Co. Canada for information Partner(s) integrity Ltd. Continuing to review evidence submitted (i.e Canadian General 1 Haizheng Road, corrective actions, information from regulatory importer(s) GMP Jiaojiand District, partner) observations Taizhou City, Zhejiang, 9999, China 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
Zhejiang Medicine Co. Canadian importer(s) contacted by Health Regulatory Data Ltd. Canada for information Partner(s) integrity Xinchang Continuing to review evidence submitted (i.e Canadian General Pharmaceutical Factory, corrective actions, information from regulatory importer(s) GMP 98 East Xinchang partner) observations Dadao Road, Xinchang, Zhejiang, 312500 China No further action required by Health Canada at this time
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Date modified: 2018-03-20
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