inspection tracker: drug manufacturing … companies that fabricate, package/label, test, ......

Home Health Canada Drugs and Health Products Reports and Publications – Drugs and Health Products Compliance and Enforcement

Inspection Tracker: Drug ManufacturingEstablishmentsAs part of Health Canada's ongoing commitment to openness and transparency, the Department ispublishing 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 trackingwith companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale inCanada. The information in the chart will expand to eventually include details about affectedCanadian companies and products.

How the Inspection Tracker WorksHealth Canada responds to potential risks as soon as we hear about them whether from ourown inspections, the companies themselves, adverse reaction reports or from our regulatorypartners.

The tracker highlights actions Health Canada is taking such as: requests for voluntaryquarantine, stop sales, import restrictions, or product recalls. It also indicates thosecircumstances where no action has been warranted.

Even if a company is listed on the tracker, it doesn't necessarily mean there is an immediate riskto 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 Canadiansusing 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 beingtaken by Health Canada at this time and there will be no more updates regarding this item.

Last update: September 26, 2017.

Open Items

https://www.canada.ca/en.html

https://www.canada.ca/en/health-canada.html

https://www.canada.ca/en/health-canada/services/drugs-health-products.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/compliance-enforcement.html

https://www.canada.ca/en.html

http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

Establishment Status of Issue

Source ofInformationunderReview

PrimaryReason forAction

Antibioticos do Brasil Rod. Professor Zeferino Vaz,Km135-SP332, Cosmopolis, SaoPaulo, Brazil 13150-000

Canadian importer(s)contacted by HealthCanada for information

Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)

Medically necessaryproducts identified

Issued terms andconditions to Canadianimporter(s)

RegulatoryPartner(s)

General GMPobservations

B. Braun Medical Inc. 2525 McGaw Avenue Irvine, CA, 92614-5895 United States








Bayer S.A Km 14.5 Calzada Roosevelt,Zona 3 De Mixco, Guatemala, N/A, 1901,Guatemala






Data Integrity


Bend Research Inc 20503 Builders Street, Bend,Oregon, USA, 97701






Data Integrity





Biocon Limited, Works Unit II Plot Nos 2-4, Phase IV, Bommasandra-Jigani LinkRoad Bangalore, Karnataka India 560099

Canadian importer(s)contacted by HealthCanada for informationContinuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)


DataIntegrity

GeneralGMPobservations

ChemRite CoPac Inc. 19725 W. Edgewood Dr.,Lannon, WI, USA




Cheng Fong Chemical Co. Ltd.No. 19, Gong 4th Road, Dayuandistrict, Taoyuan City 337,Taiwan









Chongqing Pharma ResearchInstitute Co., Ltd. No. 565 Tushan Road, NananDistrict, Chongqing, China



No further actionrequired by HealthCanada at this time


Data Integrity

Divi's Laboratories Ltd. Unit 2, Chippada Village,Bheemunipatnam,Visakhapatnam, AndhraPradesh, 531 162, India





Health Canada on-siteinspection [November 13,2017]


Data Integrity





Hetero Labs Limited Unit V Sy.No.439-441, 458 TSIIC Formulation SEZ Polepally Village, JadcherlaMandal Mahaboobnagar, Telangana India 509301





Hospira Inc. 1776 North Centennial Drive,McPherson, KS, United States,67460-9301




Issued Terms andConditions to Canadianimporter(s)

Health Canada on-siteinspection [July 24, 2017]







Hospira S.P.A Via Frosse Ardeatine 2 LIscateItaly



Requested voluntaryquarantine

Voluntary quarantine notaccepted due to productsbeing medically necessary


Related recalls and alerts:

Health Canada restrictsimports of drugs fromHospira S.P.A, Italy due todata integrity concerns


Data integrity


Interpharm Praha A.S.Komoranska 955, Praha,Modrany


Continuing to reviewevidence submitted (i.e.corrective actions,information fromregulatory partner)




http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/53779a-eng.php




INTERQUIM, S.A., C/ Joan Buscalla, 10 Sant Cugatdel Valles Barcelona, Spain









Micro Labs Tamil Nadu 92 Sipcot Industrial Complex Hosur - Tamil Nadu, Indiaf

Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner).

No medically necessaryproducts identified at thistime


Voluntary quarantine inplace



Health Canada takesaction to restrict import ofproducts from three MicroLabs facilities in India


Data integrity


http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/41963a-eng.php




Micro Labs Bangalore Plots No. 113 to 116, 4th Phase,KIADB, Bommasandra IndustrialArea, Jigani Link Road, AnekalTaluk, Bangalore, India


No medically necessaryproducts identified at thistime





Health Canada takesaction to restrict import ofproducts from three MicroLabs facilities in India







Minsheng Group ShaoxingPharmaceuticals Co. 315 Tanggong Road, PaojiandIndustrial Zone. Shaoxing,Zhejiang, China 312071





Voluntary quarantine notaccepted due to productsbeing medically necessary


Canadianimporter(s)

Data integrity


Pharmaceutics InternationalInc. 10819 Gilroy Rd, HuntValley, MD, USA, 21031










Qinhuangdao ZizhuPharmaceutical Co., Ltd No 10, Longhai Road, Economic& Technological DevelopmentZon, Qinhuangdao, Hebei China





Sage Products Inc. 3909 Three Oaks Road, Cary,Illinois, USA




Sato Kogyo Co., Ltd 9-2, Kannonji-Cho, KashiharaCity, Nara Prefecture, Japan









Sri Krishna PharmaceuticalsLtd UNIT II A-35, IDA Nacharam Hyderabad 500 076 India






Health Canada on-siteinspection [July 11, 2016]

No further action requiredby Health Canada at thistime


Health products from SriKrishna Pharmaceuticalsquarantined due to dataintegrity concerns

Release of medicallynecessary and non-medically necessaryproducts according toterms and conditions


Data integrity



https://www.canada.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/sri_krishna-eng.php#cont




Teva Pharmaceutical andChemical (Hangzhou) Co. LtdNo 1889 Jingliu Road, LinjiangIndustrial Zone, Zhejiang China






Unimark Remedies Limited(Vapi) Plot 41/42, Phase 1 - GIDC DistrictValsad Pardi, Gujarat, India






Closed Items







AGILASPECIALTIESPRIVATE LTD.,SPECIALTYFORMULATIONFACILITY (SFF) 19A, Plot No. 284-B/1Bommasandra JiganiLink Road, AnekalTaluk, BangaloreIndia - 560 105

Canadian importer(s) contacted byHealth Canada for information

Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)

Medically necessary productsidentified

Requested voluntary quarantine ofnon-medically necessary products

Voluntary quarantine in place

Issued terms and conditions toCanadian importer(s)

No further action required by HealthCanada at this time



Agila OncoTherapies Ltd. Plot No. 284/BBommasandra JiganiLink Road, IndustrialArea, Bangalore,Kamataka, India

Non-compliant rating issued



Methotrexate Injection USP 50 mg/2mL - Voluntary Recall Due to thePotential Presence of ForeignParticulate Matter


Canadianimporter(s)


http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52513a-eng.php




AGILASPECIALTIESPRIVATE LTD. Opp II M, Bilekahalli,Bannerghatta Road,Bangalore,Karnataka, India - 560 076


No critical risks identified to date




Anuh Pharma Ltd E-17/3 & E 17/4M.I.D.C. Tarapur,Taluka Palghar,District Thane, India-401 506 Boisar,Maharashtra



No medically necessary productsidentified at this time




ApotexPharmachem IndiaPrivate Limited(APIPL) Plot No. 1A,BommasandraIndustrial Area, 4thPhase, Jigani LinkRoad, Bangalore,Karnataka, India

Requested stop sale

Import restrictions imposed

On September 30, 2014, IssuedTerms and Conditions to Canadianimporter(s)


HC onsite (June 5-10) to verifyimplementation of corrective actions

On August 31, 2015, amended Termsand Conditions to Canadian importerbased on HC onsite corrective

HealthCanada RegulatoryPartner(s)

Data integrity





actions inspection conducted on June5-10

Judgments of the Federal Court setaside import restrictions on APIPLand ARPL products, ordered aretraction of statements and declaredamended terms and conditions onApotex's Establishment Licenceunlawful.


Health Canada puts measures inplace for medically necessaryproducts affected by import restrictionfrom 3 facilities in India

Apotex Product Recall (2015-04-10)

Expanded recall of Apo-Candesartan

Health Canada puts in place newoversight of Apotex Inc. imports fromAPIPL and ARPL

Summary Report

March 14, 2016: Health Canada issued anew decision which imposed no terms andconditions on Apotex's EstablishmentLicences for products fabricated at APIPLand ARPL. As such, products fabricated atthese two sites are not subject to anyimport restrictions. This decision wasbased on all available information,including new information provided byApotex.

Apotex ResearchPrivate Limited

Voluntary quarantine was in placeuntil further assessment was

HealthCanada

Data integrity

http://decisions.fct-cf.gc.ca/fc-cf/decisions/en/item/127503/index.do

http://news.gc.ca/web/article-en.do?nid=1019359



http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/52887r-eng.php



http://www.healthycanadians.gc.ca/apps/gmp-bpf/data/report/8484en.pdf




(ARPL) Plot No. 1 and No. 2,BommasandraIndustrial Area, 4thPhase, Jigani LinkRoad, Bangalore,India

completed


On September 30, 2014, issuedTerms and Conditions to Canadianimporter(s)


HC onsite (June 1-4) to verifyimplementation of corrective actions

On August 31, 2015, amended Termsand Conditions to Canadian importerbased on HC onsite correctiveactions inspection conducted on June1-4.

Judgments of the Federal Court setaside import restrictions on APIPLand ARPL products, ordered aretraction of statements and declaredamended terms and conditions onApotex's Establishment Licenceunlawful.


Health Canada requests quarantineof products for Canadian market fromApotex facility in Bangalore, India


Apotex Product Recall (2015-04-10)

Expanded recall of Apo-Candesartan




http://news.gc.ca/web/article-en.do?nid=1019359









Recall of Apo-Candesartan-HCTZ

Apo-Risperidone (2015-06-03)

Losartan-HCTZ (2015-06-03)

Health Canada puts in place newoversight of Apotex Inc. imports fromAPIPL and ARPL

Summary Report

March 14, 2016: Health Canada issued anew decision which imposed no terms andconditions on Apotex's EstablishmentLicences for products fabricated at APIPLand ARPL. As such, products fabricated atthese two sites are not subject to anyimport restrictions. This decision wasbased on all available information,including new information provided byApotex.

Beijing TaiyangPharmaceuticalIndustry Co Ltd No. 1 Shuangqiao (E)Road, Chaoyang,Beijing China






Data Integrity





http://www.healthycanadians.gc.ca/apps/gmp-bpf/data/report/8487en.pdf




CadilaPharmaceuticalsLimited. 294, G.I.D.C.Industrial Estate,Ankleshwar, India





Health Canada on-site inspection[July 18, 2016]

Health Canada on-site re-inspection[January 23, 2017]




Concord BiotechLimited 1482-1486 TrasadRoad, Dholka Ahmedabad,Gujarat 387810, India


Continuing to review evidencesubmitted (i.e corrective actions,information from regulatorypartner)

No further action required byHealth Canada at this time






CTX Life SciencesPvt. Ltd. 251-252Sachin-MagdallaRoad, G.I.D.C,Sachin, Surat,Gujarat, India,394230






Dr. Reddy'sLaboratories APIIC Ind. Est, UnitVI Pydibhimavarma(Village)Ranasthalam Mandal,Srikakulam District,India

Continuing to review evidencesubmitted (i.e corrective actions,information from regulatorypartner)No medically necessaryproducts identified at this time

Requested voluntary quarantine


Issued terms and conditions toCanadian importer(s)

Health Canada on-site inspection[September 19, 2016]



Health products quarantined from twosites in India as Health Canadaassesses data integrity concerns


Data Integrity






Dr. Reddy'sLaboratories Unit VPeddadevulapalli,Tripuraram Mandal,Nalgonad District,Andhra Pradesh






Data Integrity


Dr. Reddy'sLaboratories Unit VII Plot No. P1 toP9, Phase III,Duvvada, VSEZ,Visakhapatnam,Andhra Pradesh IN



No medically necessary productsidentified at this timeNo further actionrequired by Health Canada at thistime


Data Integrity


EmcurePharmaceuticalsLimited Plot No. P-1 & P-2,,IT-BT Park Phase II,MIDC, Hinjwadi,Hinjwadi, Pune,Maharashtra INDIA


Continuing to review evidencesubmitted (i.e. corrective actions,information from regulatory partner)

Medically necessary productsidentified Health Canada on-siteinspection [June 14, 2016]


RegulatoryPartner(s) Canadianimporter(s)

Data Integrity





EVERLIGHTCHEMICALSINDUSTRIALCORPORATION 12, Industrial ThirdRd, KuanyinIndustrial District,Kuanyin Hsiang,Taoyuan Hsien,32853, Taiwan



Health Canada on-site inspection(November 9-13)

Non-Compliant rating issued



Data Integrity

Granules IndiaLimited Plot No. 160/A,161/E, 162 & 174/A,Gagillapur Village,Qutbullapur Mandal,Ranga Reddy District,Telangana state,Hyderabad, 500043,India




RegulatoryPartner(s





HEBEI YUXING BIO-ENGINEEERING CO.LIMITED Xicheng District,Ningjin county,Ningjin, Heibei China




Requested voluntary quarantine ofnon-medically necessary products




Data Integrity

Hubei HongyuanPharmaceuticalTechnology Co. Ltd. No. 428 Yishui NorthRoad, LuotianCounty, HuanggangCity, China-438 600,Fengshan Town,Hubei Province






Hubei HongyuanPharmaceuticalTechnology Co. Ltd. No.8 FengshanRoad, Industrial andEconomicDevelopment Zone,Luotian County,China 438 600,Huanggang City,Hubei Province





Data integrity





Ind-SwiftLaboratoriesLimited Barwala Road,Bhagwanpur Village -Derabassi DistrictMohali, 140 507Punjab, India






Data integrity


Indoco RemediesLimited Plants II & III, L-32,33, 34 VernaIndustrial EstateArea, Verna, Goa,India

Canadian importer(s) contacted byHealth Canada for informationContinuing to review evidencesubmitted (i.e. corrective actions,information from regulatory partner)No further action required by HealthCanada at this time






IPCA LaboratoriesLtd. P.O. Box No. 33Village SejavtaRatlam, MadyaPradesh, India


Medically necessary productsidentified




Issued Terms and Conditions toCanadian importer(s)

Health Canada on-site inspection[September 26, 2016]



Health Canada requests quarantineof products from IPCA Laboratoriesfollowing falsification andmanipulation of data issues



Data integrity







IPCA LaboratoriesLtd Plot 65 & 99,Dandudyog IndustrialEstate, Piparia,Silvassa, Dadra &Nagar Haveli (U.T.),396 230, India


Terms and Conditions for IPCARatlam apply to the Piparia products.

Health Canada on-site inspection[August 19, 2016]



Data integrity


IPCA LaboratoriesLtd. 1 Pharma Zone, SEZPhase II, Sector 3,District Dhar,Pithampur, India





Issued terms and conditions toCanadian importer(s) Health Canadaon-site inspection [October 3, 2016]



Data integrity


inspection tracker: drug manufacturing … companies that fabricate, package/label, test, ......

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