inspection tracker: drug manufacturing … companies that fabricate, package/label, test, ......
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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
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
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Bayer S.A Km 14.5 Calzada Roosevelt,Zona 3 De Mixco, Guatemala, N/A, 1901,Guatemala
Canadian importer(s)contacted by HealthCanada for information
Medically necessaryproducts identified
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
Issued terms andconditions to Canadianimporter(s)
RegulatoryPartner(s)
Data Integrity
General GMPobservations
Bend Research Inc 20503 Builders Street, Bend,Oregon, USA, 97701
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)
Data Integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
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)
RegulatoryPartner(s)
DataIntegrity
GeneralGMPobservations
ChemRite CoPac Inc. 19725 W. Edgewood Dr.,Lannon, WI, USA
Canadian importer(s)contacted by HealthCanada for informationContinuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
RegulatoryPartner(s)
General GMPobservations
Cheng Fong Chemical Co. Ltd.No. 19, Gong 4th Road, Dayuandistrict, Taoyuan City 337,Taiwan
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
Issued terms andconditions to Canadianimporter(s)
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Chongqing Pharma ResearchInstitute Co., Ltd. No. 565 Tushan Road, NananDistrict, Chongqing, China
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
No further actionrequired by HealthCanada at this time
RegulatoryPartner(s)
Data Integrity
Divi's Laboratories Ltd. Unit 2, Chippada Village,Bheemunipatnam,Visakhapatnam, AndhraPradesh, 531 162, India
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)
Health Canada on-siteinspection [November 13,2017]
RegulatoryPartner(s)
Data Integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Hetero Labs Limited Unit V Sy.No.439-441, 458 TSIIC Formulation SEZ Polepally Village, JadcherlaMandal Mahaboobnagar, Telangana India 509301
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
RegulatoryPartner(s)
GeneralGMPobservations
Hospira Inc. 1776 North Centennial Drive,McPherson, KS, United States,67460-9301
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)
Health Canada on-siteinspection [July 24, 2017]
No further actionrequired by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Hospira S.P.A Via Frosse Ardeatine 2 LIscateItaly
Canadian importer(s)contacted by HealthCanada for information
Medically necessaryproducts identified
Requested voluntaryquarantine
Voluntary quarantine notaccepted due to productsbeing medically necessary
Issued Terms andConditions to Canadianimporter(s)
Related recalls and alerts:
Health Canada restrictsimports of drugs fromHospira S.P.A, Italy due todata integrity concerns
RegulatoryPartner(s)
Data integrity
General GMPobservations
Interpharm Praha A.S.Komoranska 955, Praha,Modrany
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.e.corrective actions,information fromregulatory partner)
Issued Terms andConditions to Canadianimporter(s)
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
INTERQUIM, S.A., C/ Joan Buscalla, 10 Sant Cugatdel Valles Barcelona, Spain
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.e.corrective actions,information fromregulatory partner)
Issued Terms andConditions to Canadianimporter(s)
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
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
Requested voluntaryquarantine
Voluntary quarantine inplace
Issued Terms andConditions to Canadianimporter(s)
Related recalls and alerts:
Health Canada takesaction to restrict import ofproducts from three MicroLabs facilities in India
RegulatoryPartner(s)
Data integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Micro Labs Bangalore Plots No. 113 to 116, 4th Phase,KIADB, Bommasandra IndustrialArea, Jigani Link Road, AnekalTaluk, Bangalore, India
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
No medically necessaryproducts identified at thistime
Requested voluntaryquarantine
Voluntary quarantine inplace
Issued Terms andConditions to Canadianimporter(s)
Related recalls and alerts:
Health Canada takesaction to restrict import ofproducts from three MicroLabs facilities in India
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Minsheng Group ShaoxingPharmaceuticals Co. 315 Tanggong Road, PaojiandIndustrial Zone. Shaoxing,Zhejiang, China 312071
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.e.corrective actions,information fromregulatory partner)
Medically necessaryproducts identified
Requested voluntaryquarantine
Voluntary quarantine notaccepted due to productsbeing medically necessary
RegulatoryPartner(s)
Canadianimporter(s)
Data integrity
General GMPobservations
Pharmaceutics InternationalInc. 10819 Gilroy Rd, HuntValley, MD, USA, 21031
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
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Qinhuangdao ZizhuPharmaceutical Co., Ltd No 10, Longhai Road, Economic& Technological DevelopmentZon, Qinhuangdao, Hebei China
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
RegulatoryPartner(s)
General GMPobservations
Sage Products Inc. 3909 Three Oaks Road, Cary,Illinois, USA
Canadian importer(s)contacted by HealthCanada for informationContinuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
RegulatoryPartner(s)
General GMPobservations
Sato Kogyo Co., Ltd 9-2, Kannonji-Cho, KashiharaCity, Nara Prefecture, Japan
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
No further actionrequired by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Sri Krishna PharmaceuticalsLtd UNIT II A-35, IDA Nacharam Hyderabad 500 076 India
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
Medically necessaryproducts identified
Requested voluntaryquarantine
Voluntary quarantine inplace
Issued Terms andConditions to Canadianimporter(s)
Health Canada on-siteinspection [July 11, 2016]
No further action requiredby Health Canada at thistime
Related recalls and alerts:
Health products from SriKrishna Pharmaceuticalsquarantined due to dataintegrity concerns
Release of medicallynecessary and non-medically necessaryproducts according toterms and conditions
RegulatoryPartner(s)
Data integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Teva Pharmaceutical andChemical (Hangzhou) Co. LtdNo 1889 Jingliu Road, LinjiangIndustrial Zone, Zhejiang China
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
No further actionrequired by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
Unimark Remedies Limited(Vapi) Plot 41/42, Phase 1 - GIDC DistrictValsad Pardi, Gujarat, India
Canadian importer(s)contacted by HealthCanada for information
Continuing to reviewevidence submitted (i.ecorrective actions,information fromregulatory partner)
Issued Terms andConditions to Canadianimporter(s)
RegulatoryPartner(s)
General GMPobservations
Closed Items
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
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
RegulatoryPartner(s)
General GMPobservations
Agila OncoTherapies Ltd. Plot No. 284/BBommasandra JiganiLink Road, IndustrialArea, Bangalore,Kamataka, India
Non-compliant rating issued
No further action required by HealthCanada at this time
Related recalls and alerts:
Methotrexate Injection USP 50 mg/2mL - Voluntary Recall Due to thePotential Presence of ForeignParticulate Matter
RegulatoryPartner(s)
Canadianimporter(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
AGILASPECIALTIESPRIVATE LTD. Opp II M, Bilekahalli,Bannerghatta Road,Bangalore,Karnataka, India - 560 076
Canadian importer(s) contacted byHealth Canada for information
No critical risks identified to date
No further action required by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
Anuh Pharma Ltd E-17/3 & E 17/4M.I.D.C. Tarapur,Taluka Palghar,District Thane, India-401 506 Boisar,Maharashtra
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified at this time
No further action required by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
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)
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
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
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
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.
Related recalls and alerts:
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
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
(ARPL) Plot No. 1 and No. 2,BommasandraIndustrial Area, 4thPhase, Jigani LinkRoad, Bangalore,India
completed
Import restrictions imposed
On September 30, 2014, issuedTerms and Conditions to Canadianimporter(s)
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
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.
Related recalls and alerts:
Health Canada requests quarantineof products for Canadian market fromApotex facility in Bangalore, India
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
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
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
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified at this time
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data Integrity
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
CadilaPharmaceuticalsLimited. 294, G.I.D.C.Industrial Estate,Ankleshwar, India
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified 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 HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
Concord BiotechLimited 1482-1486 TrasadRoad, Dholka Ahmedabad,Gujarat 387810, India
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatorypartner)
No further action required byHealth Canada at this time
RegulatoryPartner(s)
GeneralGMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
CTX Life SciencesPvt. Ltd. 251-252Sachin-MagdallaRoad, G.I.D.C,Sachin, Surat,Gujarat, India,394230
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No further action required by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
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
Voluntary quarantine in place
Issued terms and conditions toCanadian importer(s)
Health Canada on-site inspection[September 19, 2016]
No further action required by HealthCanada at this time
Related recalls and alerts:
Health products quarantined from twosites in India as Health Canadaassesses data integrity concerns
RegulatoryPartner(s)
Data Integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Dr. Reddy'sLaboratories Unit VPeddadevulapalli,Tripuraram Mandal,Nalgonad District,Andhra Pradesh
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified at this time
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data Integrity
General GMPobservations
Dr. Reddy'sLaboratories Unit VII Plot No. P1 toP9, Phase III,Duvvada, VSEZ,Visakhapatnam,Andhra Pradesh IN
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified at this timeNo further actionrequired by Health Canada at thistime
RegulatoryPartner(s)
Data Integrity
General GMPobservations
EmcurePharmaceuticalsLimited Plot No. P-1 & P-2,,IT-BT Park Phase II,MIDC, Hinjwadi,Hinjwadi, Pune,Maharashtra INDIA
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e. corrective actions,information from regulatory partner)
Medically necessary productsidentified Health Canada on-siteinspection [June 14, 2016]
No further action required by HealthCanada at this time
RegulatoryPartner(s) Canadianimporter(s)
Data Integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
EVERLIGHTCHEMICALSINDUSTRIALCORPORATION 12, Industrial ThirdRd, KuanyinIndustrial District,Kuanyin Hsiang,Taoyuan Hsien,32853, Taiwan
Canadian importer(s) contacted byHealth Canada for information
No medically necessary productsidentified at this time
Health Canada on-site inspection(November 9-13)
Non-Compliant rating issued
No further action required by HealthCanada at this time
RegulatoryPartner(s)
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
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No further action required by HealthCanada at this time
RegulatoryPartner(s
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
HEBEI YUXING BIO-ENGINEEERING CO.LIMITED Xicheng District,Ningjin county,Ningjin, Heibei China
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified at this time
Requested voluntary quarantine ofnon-medically necessary products
Voluntary quarantine in place
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data Integrity
Hubei HongyuanPharmaceuticalTechnology Co. Ltd. No. 428 Yishui NorthRoad, LuotianCounty, HuanggangCity, China-438 600,Fengshan Town,Hubei Province
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No further action required by HealthCanada at this time
RegulatoryPartner(s)
General GMPobservations
Hubei HongyuanPharmaceuticalTechnology Co. Ltd. No.8 FengshanRoad, Industrial andEconomicDevelopment Zone,Luotian County,China 438 600,Huanggang City,Hubei Province
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
Ind-SwiftLaboratoriesLimited Barwala Road,Bhagwanpur Village -Derabassi DistrictMohali, 140 507Punjab, India
Canadian importer(s) contacted byHealth Canada for information
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No critical risks identified to date
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data integrity
General GMPobservations
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
RegulatoryPartner(s)
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
IPCA LaboratoriesLtd. P.O. Box No. 33Village SejavtaRatlam, MadyaPradesh, India
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
Medically necessary productsidentified
Requested voluntary quarantine
Voluntary quarantine in place
Import restrictions imposed
Issued Terms and Conditions toCanadian importer(s)
Health Canada on-site inspection[September 26, 2016]
No further action required by HealthCanada at this time
Related recalls and alerts:
Health Canada requests quarantineof products from IPCA Laboratoriesfollowing falsification andmanipulation of data issues
Health Canada puts measures inplace for medically necessaryproducts affected by import restrictionfrom 3 facilities in India
RegulatoryPartner(s)
Data integrity
General GMPobservations
Establishment Status of Issue
Source ofInformationunderReview
PrimaryReason forAction
IPCA LaboratoriesLtd Plot 65 & 99,Dandudyog IndustrialEstate, Piparia,Silvassa, Dadra &Nagar Haveli (U.T.),396 230, India
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
Terms and Conditions for IPCARatlam apply to the Piparia products.
Health Canada on-site inspection[August 19, 2016]
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data integrity
General GMPobservations
IPCA LaboratoriesLtd. 1 Pharma Zone, SEZPhase II, Sector 3,District Dhar,Pithampur, India
Continuing to review evidencesubmitted (i.e corrective actions,information from regulatory partner)
No medically necessary productsidentified at this time
Requested voluntary quarantine
Voluntary quarantine in place
Issued terms and conditions toCanadian importer(s) Health Canadaon-site inspection [October 3, 2016]
No further action required by HealthCanada at this time
RegulatoryPartner(s)
Data integrity
General GMPobservations
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