Health Canada · 2022

Distribution Pharmaplus Inc.Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control · Stability and storage 2022-12-20 5 findings Laboval Inc.Computer system validation · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-12-20 4 findings Brenntag Canada Inc.Other quality system · Equipment and facility · Stability and storage · Laboratory and QC controls 2022-12-19 5 findings Kohl & Frisch LimitedStability and storage · Other quality system · Equipment and facility 2022-12-19 5 findings Linde Canada Inc.Equipment and facility · Quality unit oversight · Other quality system 2022-12-14 3 findings Unither Biotech Inc.Other quality system · Labeling and packaging 2022-12-14 3 findings Fort Garry SuppliesOther quality system · Equipment and facility · Stability and storage 2022-12-13 4 findings Clarion Medical Technologies Inc.Quality unit oversight · Complaint and recall handling · Stability and storage 2022-12-13 3 findings MHCare Medical CorporationLaboratory and QC controls · Stability and storage · Regulatory reporting and change control · Other quality system 2022-12-12 4 findings Produits Chimiques Regent LteeComplaint and recall handling · Other quality system · Computer system validation · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Stability and storage · Regulatory reporting and change control 2022-12-12 11 findings Galenova Inc.Other quality system · Equipment and facility · Computer system validation 2022-12-12 3 findings Ontario Medical Oxygen Services Inc.Computer system validation · Other quality system · Regulatory reporting and change control · Equipment and facility · Quality unit oversight 2022-12-07 7 findings Kohl & Frisch LimitedOther quality system · Complaint and recall handling · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility · Regulatory reporting and change control 2022-12-06 9 findings Novartis Pharmaceuticals Canada IncOther quality system · Laboratory and QC controls · Labeling and packaging · Deviation, CAPA, and investigation · Complaint and recall handling · Equipment and facility · Stability and storage 2022-12-06 10 findings UpHealth Pharma IncMaterial and supplier control · Equipment and facility · Other quality system 2022-12-02 3 findings Shinpharma IncStability and storage · Regulatory reporting and change control · Other quality system 2022-12-01 4 findings Altamed PharmaDeviation, CAPA, and investigation · Quality unit oversight · Equipment and facility · Complaint and recall handling · Other quality system 2022-11-29 6 findings Nora Pharma IncEquipment and facility · Deviation, CAPA, and investigation · Other quality system · Complaint and recall handling · Quality unit oversight 2022-11-29 7 findings Linde Canada Inc.Complaint and recall handling · Cleaning validation · Computer system validation 2022-11-29 3 findings Air Liquide Canada Inc.Equipment and facility · Laboratory and QC controls · Regulatory reporting and change control 2022-11-29 4 findings Linde Canada Inc.Complaint and recall handling · Quality unit oversight · Deviation, CAPA, and investigation · Computer system validation · Equipment and facility · Other quality system 2022-11-25 6 findings Canadian Analytical Laboratories division of Reena Group Inc.Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility 2022-11-24 6 findings Air Liquide Canada Inc.Other quality system · Regulatory reporting and change control · Complaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation · Computer system validation 2022-11-24 7 findings Laboratoires NovaSpec Inc.Deviation, CAPA, and investigation · Labeling and packaging · Training and personnel · Computer system validation · Equipment and facility · Regulatory reporting and change control · Laboratory and QC controls · Other quality system 2022-11-23 10 findings Distrivet Inc.Equipment and facility · Other quality system · Training and personnel · Stability and storage 2022-11-22 5 findings Resilience Biotechnologies Inc.Other quality system · Laboratory and QC controls · Aseptic processing and sterility assurance 2022-11-21 5 findings AX Pharmaceutical CorpCleaning validation · Deviation, CAPA, and investigation · Stability and storage · Training and personnel · Other quality system · Laboratory and QC controls 2022-11-21 8 findings Serum Institute of India Pvt. Ltd.Computer system validation · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2022-11-17 7 findings Serum Institute of India Pvt. Ltd.Aseptic processing and sterility assurance · Stability and storage · Other quality system · Regulatory reporting and change control · Equipment and facility 2022-11-17 7 findings Serum Institute of India Pvt. Ltd.Material and supplier control · Other quality system · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility · Computer system validation 2022-11-17 10 findings Angita Pharma Inc.Other quality system · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation 2022-11-17 6 findings Orimed Pharma IncOther quality system · Deviation, CAPA, and investigation · Equipment and facility 2022-11-17 5 findings Jamp Pharma CorporationRegulatory reporting and change control · Other quality system · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation · Complaint and recall handling · Labeling and packaging 2022-11-17 11 findings Piramal Healthcare (Canada) LimitedMaterial and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system · Complaint and recall handling 2022-11-14 5 findings KDC/One Development Corporation Inc.Validation and qualification · Material and supplier control · Computer system validation · Equipment and facility · Cleaning validation · Training and personnel · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-11-14 12 findings VitalAire Canada IncOther quality system · Equipment and facility · Training and personnel · Labeling and packaging 2022-11-14 7 findings Packmetrics Inc.Other quality system · Stability and storage 2022-11-09 3 findings Linde Canada Inc.Deviation, CAPA, and investigation · Training and personnel · Other quality system · Quality unit oversight · Equipment and facility 2022-11-09 6 findings Linde Canada Inc.Quality unit oversight · Equipment and facility · Regulatory reporting and change control · Other quality system · Complaint and recall handling · Deviation, CAPA, and investigation 2022-11-09 7 findings Toronto General Hospital, University Health NetworkComputer system validation · Deviation, CAPA, and investigation · Equipment and facility · Stability and storage 2022-11-09 4 findings Occy Laboratoire Inc.Deviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls · Other quality system · Cleaning validation · Regulatory reporting and change control · Computer system validation · Contamination control · Equipment and facility 2022-11-09 10 findings 2179267 Ontario Ltd. O/A Britman Packaging ServicesComplaint and recall handling · Laboratory and QC controls · Stability and storage · Computer system validation · Cleaning validation 2022-11-08 7 findings BGP Pharma ULCOther quality system · Laboratory and QC controls · Deviation, CAPA, and investigation 2022-11-07 4 findings Mylan Pharmaceuticals ULCRegulatory reporting and change control · Laboratory and QC controls · Deviation, CAPA, and investigation · Contamination control · Stability and storage · Other quality system 2022-11-07 7 findings Applied Chemistry Labs Ltd.Other quality system · Equipment and facility · Regulatory reporting and change control 2022-11-07 7 findings Air Liquide Canada Inc.Other quality system · Complaint and recall handling 2022-11-03 3 findings TJP Labs Inc.Labeling and packaging · Stability and storage · Material and supplier control 2022-11-02 3 findings Neopharm LavalComputer system validation · Laboratory and QC controls · Other quality system · Equipment and facility 2022-11-01 7 findings Mediscope Ltd.Equipment and facility · Other quality system · Laboratory and QC controls 2022-11-01 3 findings Linde Canada Inc.Other quality system · Computer system validation · Quality unit oversight 2022-10-26 5 findings Sanofi Pasteur Inc.Equipment and facility · Cleaning validation · Contamination control · Other quality system · Complaint and recall handling 2022-10-24 5 findings Auro Pharma IncDeviation, CAPA, and investigation · Other quality system · Labeling and packaging 2022-10-24 3 findings BioVectra IncComputer system validation · Material and supplier control · Contamination control · Other quality system · Laboratory and QC controls · Stability and storage 2022-10-24 9 findings Groupe Dissan Inc.Laboratory and QC controls · Other quality system · Regulatory reporting and change control · Computer system validation · Equipment and facility · Stability and storage 2022-10-19 12 findings Steri-Med Pharma Inc.Material and supplier control · Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Computer system validation · Stability and storage · Cleaning validation · Deviation, CAPA, and investigation 2022-10-18 14 findings The Stevens Company LimitedDeviation, CAPA, and investigation · Complaint and recall handling · Equipment and facility · Regulatory reporting and change control · Other quality system 2022-10-18 6 findings Nucro-TechnicsStability and storage · Laboratory and QC controls · Deviation, CAPA, and investigation · Computer system validation · Other quality system 2022-10-18 5 findings Hetero Labs LimitedEquipment and facility · Stability and storage · Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Computer system validation · Complaint and recall handling · Laboratory and QC controls 2022-10-17 10 findings Covar Pharmaceuticals Inc.Computer system validation · Other quality system · Validation and qualification · Contamination control · Material and supplier control · Laboratory and QC controls 2022-10-17 7 findings The Fertility Partners Inc.Equipment and facility · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation 2022-09-28 5 findings B. Braun of Canada Ltd.Equipment and facility · Other quality system · Quality unit oversight · Regulatory reporting and change control 2022-09-27 4 findings Colgate-Palmolive Canada Inc.Equipment and facility · Deviation, CAPA, and investigation · Other quality system 2022-09-27 4 findings Church & Dwight Canada Corp.Other quality system · Computer system validation · Cleaning validation · Equipment and facility · Complaint and recall handling · Deviation, CAPA, and investigation · Quality unit oversight 2022-09-27 12 findings Vita Bee Health Canada Ltd.Stability and storage · Other quality system · Equipment and facility 2022-09-27 6 findings IPCA Laboratories LimitedMaterial and supplier control · Laboratory and QC controls · Other quality system · Computer system validation 2022-09-26 5 findings 10051300 Manitoba Ltd.Stability and storage · Other quality system · Equipment and facility 2022-09-22 3 findings Patheon Inc.Stability and storage · Laboratory and QC controls · Deviation, CAPA, and investigation · Cleaning validation · Equipment and facility · Documentation and records · Regulatory reporting and change control · Other quality system 2022-09-21 11 findings Sylvia Fedoruk Canadian Centre for Nuclear InnovationEquipment and facility · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance 2022-09-20 3 findings B. Braun Medical Inc.Equipment and facility · Other quality system · Material and supplier control · Deviation, CAPA, and investigation 2022-09-20 6 findings Protonify CorporationOther quality system · Validation and qualification · Equipment and facility · Deviation, CAPA, and investigation · Material and supplier control · Quality unit oversight · Cleaning validation · Complaint and recall handling · Computer system validation 2022-09-19 16 findings Aurobindo Pharma Ltd. (Unit VII)Computer system validation · Quality unit oversight · Deviation, CAPA, and investigation · Other quality system 2022-09-19 4 findings Confab Laboratories, Inc.Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Documentation and records · Computer system validation · Material and supplier control · Labeling and packaging 2022-09-14 9 findings Avir Pharma Inc.Laboratory and QC controls · Stability and storage 2022-09-13 3 findings Dentec Safety Specialists Inc.Laboratory and QC controls · Other quality system · Regulatory reporting and change control 2022-09-13 4 findings Terumo BCT (Canada) Inc.Labeling and packaging · Equipment and facility · Other quality system · Complaint and recall handling 2022-09-13 6 findings Laboratoire Riva Inc.Regulatory reporting and change control · Labeling and packaging · Equipment and facility · Other quality system · Cleaning validation · Material and supplier control · Stability and storage · Laboratory and QC controls 2022-09-13 13 findings Azelis Canada IncStability and storage · Other quality system · Material and supplier control · Regulatory reporting and change control · Equipment and facility · Training and personnel · Labeling and packaging · Complaint and recall handling · Quality unit oversight 2022-09-12 14 findings Shilpa Medicare LimitedRegulatory reporting and change control · Aseptic processing and sterility assurance · Other quality system · Cleaning validation · Contamination control · Material and supplier control · Equipment and facility 2022-09-12 10 findings Topcon Canada Inc.Other quality system · Complaint and recall handling · Stability and storage · Regulatory reporting and change control · Deviation, CAPA, and investigation 2022-09-08 7 findings Herbion CanadaOther quality system · Equipment and facility 2022-09-07 3 findings Syndel Laboratories LtdOther quality system · Stability and storage · Deviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control 2022-09-07 6 findings ILS Pharma IncEquipment and facility · Computer system validation · Laboratory and QC controls · Deviation, CAPA, and investigation · Regulatory reporting and change control 2022-09-07 8 findings Polymed Chirurgical Inc.Equipment and facility · Other quality system · Complaint and recall handling 2022-09-06 3 findings Nitrous Oxide Of Canada, A Division Of Red-D-ArcOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Complaint and recall handling · Laboratory and QC controls · Regulatory reporting and change control 2022-09-01 10 findings Hill Dermaceuticals Inc.Training and personnel · Regulatory reporting and change control · Other quality system · Stability and storage · Cleaning validation · Quality unit oversight 2022-08-31 7 findings Delmar Chemicals Inc./Les Produits Chimiques Delmar Inc.Laboratory and QC controls · Validation and qualification 2022-08-30 3 findings Fratum Pharma Inc. (Division of Euro-Pharm International Canada Inc.)Other quality system · Computer system validation · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Labeling and packaging · Cleaning validation 2022-08-30 8 findings Bracco Imaging CanadaLaboratory and QC controls · Equipment and facility · Complaint and recall handling · Stability and storage 2022-08-30 5 findings Exzell Pharma Inc.Computer system validation · Material and supplier control · Equipment and facility 2022-08-30 3 findings Vivier Canada IncorporatedDeviation, CAPA, and investigation · Stability and storage · Complaint and recall handling · Other quality system · Training and personnel · Equipment and facility 2022-08-30 7 findings Ontario Medical Supply Inc.Other quality system · Laboratory and QC controls · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control 2022-08-29 11 findings Sporometrics Inc.Other quality system · Deviation, CAPA, and investigation 2022-08-23 3 findings ICU Medical Canada Inc.Complaint and recall handling · Other quality system · Equipment and facility · Quality unit oversight · Stability and storage · Regulatory reporting and change control · Laboratory and QC controls 2022-08-23 8 findings Eurofins Biopharma Product Testing Toronto Inc.Other quality system · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance · Regulatory reporting and change control · Contamination control · Laboratory and QC controls 2022-08-22 8 findings Recordati Rare Diseases Canada Inc.Other quality system · Equipment and facility · Quality unit oversight 2022-08-17 3 findings Thunder Bay Regional Health Sciences CentreStability and storage · Computer system validation · Deviation, CAPA, and investigation · Complaint and recall handling · Other quality system 2022-08-15 5 findings MendeliKABS Inc.Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Training and personnel · Computer system validation 2022-08-15 5 findings PBG BioPharma Inc.Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control · Stability and storage · Other quality system 2022-08-11 5 findings Knight Therapeutics Inc.Regulatory reporting and change control · Training and personnel · Complaint and recall handling · Quality unit oversight · Deviation, CAPA, and investigation · Equipment and facility · Other quality system 2022-08-08 9 findings PBR Laboratories Inc.Regulatory reporting and change control · Equipment and facility · Other quality system · Stability and storage · Aseptic processing and sterility assurance 2022-08-08 10 findings ANB Canada Inc.Quality unit oversight · Stability and storage · Other quality system · Equipment and facility 2022-08-03 6 findings Shoppers Drug Mart Specialty Health Network Inc.Equipment and facility · Regulatory reporting and change control · Other quality system · Complaint and recall handling · Stability and storage 2022-08-03 7 findings Edmonton Radiopharmaceutical Centre (Alberta Health Services)Other quality system · Validation and qualification · Deviation, CAPA, and investigation · Contamination control · Equipment and facility · Environmental monitoring · Stability and storage 2022-08-02 7 findings Central Sales LimitedOther quality system · Equipment and facility · Laboratory and QC controls 2022-08-02 4 findings Sunstar Americas Inc.Other quality system · Stability and storage 2022-08-02 3 findings Curium Canada Inc.Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls · Complaint and recall handling 2022-08-01 4 findings Juno OTC Inc.Laboratory and QC controls · Validation and qualification · Other quality system · Complaint and recall handling · Deviation, CAPA, and investigation · Labeling and packaging · Regulatory reporting and change control · Material and supplier control 2022-07-28 10 findings Oxymed, Div. De 118303 Canada Inc.Equipment and facility · Computer system validation · Cleaning validation · Laboratory and QC controls 2022-07-27 5 findings Natco Pharma (Canada) IncComplaint and recall handling · Stability and storage · Other quality system · Quality unit oversight · Labeling and packaging 2022-07-26 8 findings Quadra Chemicals Ltd.Other quality system · Equipment and facility · Labeling and packaging · Stability and storage · Regulatory reporting and change control · Complaint and recall handling · Training and personnel 2022-07-26 10 findings LEO Pharma IncStability and storage · Other quality system · Regulatory reporting and change control · Laboratory and QC controls · Deviation, CAPA, and investigation 2022-07-26 7 findings Cosmaceutical Research Lab Inc.Cleaning validation · Labeling and packaging · Stability and storage · Other quality system · Laboratory and QC controls 2022-07-26 8 findings CDMV Inc.Deviation, CAPA, and investigation · Complaint and recall handling · Other quality system 2022-07-22 3 findings Ferring Inc.Stability and storage · Other quality system · Equipment and facility 2022-07-20 3 findings National Research Council of Canada (Biologics Manufacturing Centre) / Conseil national de recherches Canada (Centre de production de produits biologiques)Equipment and facility · Validation and qualification · Other quality system · Stability and storage 2022-07-18 8 findings McKesson Canada CorporationDeviation, CAPA, and investigation · Other quality system · Complaint and recall handling · Stability and storage 2022-07-18 6 findings Viva Pharmaceutical Inc.Other quality system · Regulatory reporting and change control · Equipment and facility · Laboratory and QC controls · Computer system validation 2022-07-11 10 findings Bausch Health Companies Inc.Equipment and facility · Computer system validation · Other quality system · Validation and qualification · Deviation, CAPA, and investigation · Stability and storage 2022-07-11 11 findings B.M.S. EnterprisesStability and storage · Other quality system 2022-06-28 3 findings HK Kolmar Canada, Inc.Other quality system · Material and supplier control 2022-06-28 3 findings Brenntag Canada Inc.Stability and storage · Laboratory and QC controls · Computer system validation · Other quality system · Equipment and facility 2022-06-28 8 findings Laboratoires Delon (1990) Inc.Stability and storage · Other quality system · Laboratory and QC controls 2022-06-27 3 findings Sri Krishna Pharmaceuticals LtdLaboratory and QC controls · Cleaning validation · Equipment and facility 2022-06-23 4 findings Labs-Mart Inc.Computer system validation · Deviation, CAPA, and investigation · Regulatory reporting and change control · Material and supplier control 2022-06-21 4 findings Glopec International Inc.Labeling and packaging · Complaint and recall handling · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Other quality system 2022-06-21 8 findings Alumier Labs Inc.Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Complaint and recall handling · Equipment and facility · Stability and storage 2022-06-21 8 findings Elizabeth Arden (Canada) LimitedStability and storage · Complaint and recall handling · Other quality system · Equipment and facility 2022-06-20 5 findings Pharmacia & Upjohn Company LLCOther quality system · Computer system validation · Cleaning validation · Aseptic processing and sterility assurance · Equipment and facility 2022-06-20 5 findings Vivin Drugs & Pharmaceuticals LimitedCleaning validation · Laboratory and QC controls · Equipment and facility 2022-06-20 4 findings Specialty Connect Logistics Inc.Training and personnel · Stability and storage · Other quality system 2022-06-15 4 findings Argus Laboratory IncDeviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control · Other quality system · Laboratory and QC controls · Material and supplier control 2022-06-14 7 findings Altius Healthcare Inc.Other quality system · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control 2022-06-14 7 findings AbbVie Inc.Aseptic processing and sterility assurance · Other quality system · Complaint and recall handling · Equipment and facility 2022-06-13 6 findings AbbVie Inc.Computer system validation · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls 2022-06-13 4 findings AbbVie Inc.Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility · Other quality system · Contamination control 2022-06-13 8 findings PF Consumer Healthcare Canada ULCEquipment and facility · Other quality system · Complaint and recall handling · Deviation, CAPA, and investigation · Quality unit oversight 2022-06-13 8 findings Sharon Bio-Medicine LimitedComplaint and recall handling · Deviation, CAPA, and investigation · Computer system validation · Cleaning validation · Other quality system · Equipment and facility · Labeling and packaging · Material and supplier control · Contamination control · Quality unit oversight 2022-06-13 16 findings Medicago USA Inc.Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Material and supplier control · Other quality system · Validation and qualification · Cleaning validation 2022-06-13 9 findings Sun Pharmaceutical Industries LimitedDeviation, CAPA, and investigation · Contamination control · Computer system validation · Cleaning validation · Laboratory and QC controls · Training and personnel · Equipment and facility 2022-06-13 9 findings Canadian Pharmaceutical Supply Ltd.Other quality system · Equipment and facility · Stability and storage 2022-06-09 4 findings British Columbia Centre for Disease Control and Prevention Society BranchComplaint and recall handling · Computer system validation · Stability and storage · Laboratory and QC controls · Training and personnel 2022-06-08 7 findings Logistic Support Unit Inc. (Now operating under DEL 3-002794-A)Other quality system 2022-06-08 3 findings Messer Canada Inc.Quality unit oversight · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation 2022-06-08 4 findings Beauty Mark Solutions IncEquipment and facility · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Regulatory reporting and change control · Other quality system · Quality unit oversight · Laboratory and QC controls 2022-06-08 13 findings Jubilant Generics LimitedEquipment and facility · Quality unit oversight · Other quality system · Computer system validation 2022-06-06 7 findings Ind-Swift Ltd.Other quality system · Equipment and facility · Laboratory and QC controls · Cleaning validation · Deviation, CAPA, and investigation 2022-06-06 8 findings Alberta Health ServicesDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system · Material and supplier control 2022-06-06 6 findings Belvedere International Inc.Labeling and packaging · Other quality system · Equipment and facility · Regulatory reporting and change control · Material and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls · Training and personnel · Computer system validation 2022-06-01 12 findings All Clean Natural Ltd.Other quality system · Equipment and facility · Cleaning validation · Training and personnel · Material and supplier control · Stability and storage · Computer system validation · Deviation, CAPA, and investigation 2022-06-01 14 findings HFC Prestige International Canada, Inc.Other quality system · Equipment and facility · Regulatory reporting and change control · Stability and storage 2022-05-31 5 findings Delta Pharma Inc.Computer system validation · Other quality system · Cleaning validation · Training and personnel · Deviation, CAPA, and investigation · Labeling and packaging · Complaint and recall handling 2022-05-31 7 findings Delta Pharma Inc.Other quality system · Equipment and facility · Complaint and recall handling · Training and personnel · Labeling and packaging · Stability and storage · Cleaning validation · Computer system validation · Deviation, CAPA, and investigation 2022-05-31 12 findings IntelliPharmaCeutics Corp.Deviation, CAPA, and investigation · Stability and storage · Other quality system · Equipment and facility · Training and personnel · Complaint and recall handling · Cleaning validation 2022-05-31 10 findings Baxter CorporationOther quality system · Equipment and facility · Deviation, CAPA, and investigation 2022-05-31 4 findings Halo Pharmaceutical Canada Inc.Laboratory and QC controls · Complaint and recall handling · Deviation, CAPA, and investigation · Other quality system · Equipment and facility · Material and supplier control · Cleaning validation · Training and personnel 2022-05-30 11 findings Centre for Probe Development and CommercializationAseptic processing and sterility assurance · Other quality system · Deviation, CAPA, and investigation 2022-05-30 3 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedAseptic processing and sterility assurance · Laboratory and QC controls · Other quality system · Contamination control 2022-05-30 4 findings Advantage Solutions Inc.Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Regulatory reporting and change control · Labeling and packaging 2022-05-27 6 findings Vivariant Laboratories Inc.Computer system validation · Training and personnel · Other quality system · Equipment and facility 2022-05-25 4 findings Médi-Sélect LtéeComputer system validation · Complaint and recall handling · Equipment and facility · Regulatory reporting and change control · Stability and storage · Other quality system 2022-05-25 7 findings Pro-TamOther quality system · Complaint and recall handling · Deviation, CAPA, and investigation · Regulatory reporting and change control · Stability and storage 2022-05-25 5 findings CDMV Inc.Other quality system · Stability and storage · Regulatory reporting and change control · Equipment and facility 2022-05-25 5 findings Galderma Canada IncOther quality system · Deviation, CAPA, and investigation · Complaint and recall handling · Regulatory reporting and change control 2022-05-24 5 findings Teamworks ManufacturingLaboratory and QC controls · Other quality system · Material and supplier control · Regulatory reporting and change control · Computer system validation 2022-05-24 11 findings Quantus Products & Services Inc.Computer system validation · Stability and storage · Other quality system · Training and personnel 2022-05-24 5 findings Zochem ULCMaterial and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls · Regulatory reporting and change control 2022-05-24 5 findings Canadian Analytical Laboratories division of Reena Group Inc.Regulatory reporting and change control · Deviation, CAPA, and investigation · Other quality system · Computer system validation · Laboratory and QC controls · Equipment and facility 2022-05-24 7 findings Dermolab Pharma LtéeOther quality system · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-05-18 3 findings Avari Medical Ltd.Equipment and facility · Stability and storage · Other quality system 2022-05-18 3 findings Jamieson Laboratories Ltd.Labeling and packaging · Other quality system · Laboratory and QC controls · Equipment and facility · Computer system validation · Deviation, CAPA, and investigation · Contamination control · Stability and storage 2022-05-17 11 findings Xediton Pharmaceuticals IncOther quality system · Training and personnel · Validation and qualification · Regulatory reporting and change control · Labeling and packaging · Deviation, CAPA, and investigation · Complaint and recall handling 2022-05-17 9 findings Nualtis Corp.Labeling and packaging · Equipment and facility · Computer system validation · Other quality system 2022-05-16 4 findings Erfa Canada 2012 IncOther quality system · Stability and storage · Complaint and recall handling · Equipment and facility · Quality unit oversight · Labeling and packaging · Laboratory and QC controls · Deviation, CAPA, and investigation · Regulatory reporting and change control 2022-05-16 18 findings Catalent Ontario LimitedComputer system validation · Cleaning validation · Equipment and facility · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation 2022-05-16 8 findings Winnipeg Regional Health AuthorityLaboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Other quality system 2022-05-16 5 findings Jubilant Draximage Inc. dba Jubilant RadiopharmaDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system 2022-05-10 4 findings Kuehne + Nagel Ltd.Deviation, CAPA, and investigation · Other quality system · Training and personnel 2022-05-10 5 findings Kuehne + Nagel Ltd.Other quality system · Regulatory reporting and change control · Equipment and facility · Deviation, CAPA, and investigation · Computer system validation 2022-05-10 6 findings G Production Inc.Stability and storage · Regulatory reporting and change control · Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility · Computer system validation · Labeling and packaging · Other quality system · Quality unit oversight · Complaint and recall handling 2022-05-09 13 findings Eurofins CDMO Alphora IncorporatedEquipment and facility · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Stability and storage · Complaint and recall handling · Regulatory reporting and change control · Contamination control · Computer system validation 2022-05-05 13 findings Eurofins CDMO Alphora IncorporatedComputer system validation · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls · Other quality system · Complaint and recall handling 2022-05-05 9 findings CHX Technologies IncOther quality system · Equipment and facility · Laboratory and QC controls · Regulatory reporting and change control · Stability and storage 2022-05-03 7 findings GasPro, division of ProResp Inc.Quality unit oversight · Computer system validation · Other quality system · Labeling and packaging 2022-05-03 5 findings GasPro, division of ProResp Inc.Computer system validation · Other quality system · Equipment and facility 2022-04-27 4 findings TJP Labs Inc.Stability and storage · Material and supplier control · Other quality system · Equipment and facility 2022-04-27 6 findings Diversey Canada Inc.Computer system validation · Complaint and recall handling · Material and supplier control · Quality unit oversight · Laboratory and QC controls · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system · Training and personnel 2022-04-27 11 findings Messer Canada Inc.Quality unit oversight · Equipment and facility · Laboratory and QC controls · Material and supplier control · Other quality system · Cleaning validation · Computer system validation 2022-04-26 12 findings Hikma Canada LimitedRegulatory reporting and change control · Complaint and recall handling · Other quality system · Equipment and facility · Labeling and packaging 2022-04-26 5 findings Laboratoires K.A.B.S. Inc.Deviation, CAPA, and investigation · Computer system validation · Other quality system · Training and personnel · Stability and storage · Equipment and facility · Material and supplier control · Regulatory reporting and change control · Laboratory and QC controls 2022-04-20 12 findings Ottawa Fertility Centre Inc.Other quality system · Stability and storage 2022-04-20 3 findings Capcium Inc.Training and personnel · Labeling and packaging · Stability and storage · Computer system validation · Other quality system 2022-04-19 5 findings PNP Pharmaceuticals Inc.Quality unit oversight · Other quality system · Regulatory reporting and change control · Complaint and recall handling · Equipment and facility 2022-04-11 8 findings Merle Norman Cosmetics IncOther quality system · Regulatory reporting and change control · Complaint and recall handling · Equipment and facility · Quality unit oversight · Stability and storage 2022-04-05 7 findings Netchem IncEquipment and facility · Stability and storage · Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control 2022-04-05 7 findings Estée Lauder Cosmetics Ltd.Equipment and facility · Labeling and packaging · Complaint and recall handling 2022-03-30 4 findings Hughes Decorr - Design & DisplayOther quality system · Stability and storage 2022-03-30 3 findings Estée Lauder Cosmetics Ltd.Labeling and packaging · Training and personnel · Other quality system 2022-03-28 3 findings Sanofi Vaccines Canada Ltd.Other quality system · Stability and storage 2022-03-28 3 findings Altamed PharmaLaboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation 2022-03-23 5 findings Aspen Pharmacare Canada Inc.Regulatory reporting and change control · Other quality system · Laboratory and QC controls 2022-03-23 3 findings Nora Pharma IncOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control · Stability and storage 2022-03-23 6 findings Neopharm Labs Inc.Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls 2022-03-22 4 findings Canadian Blood ServicesDeviation, CAPA, and investigation · Material and supplier control · Equipment and facility · Laboratory and QC controls · Other quality system 2022-03-22 5 findings Catalent Ontario LimitedMaterial and supplier control · Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Laboratory and QC controls · Validation and qualification 2022-03-22 8 findings Macopharma Canada Inc.Other quality system · Training and personnel · Stability and storage 2022-03-22 7 findings Estée Lauder Cosmetics Ltd.Training and personnel · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Computer system validation · Complaint and recall handling · Other quality system · Material and supplier control · Stability and storage 2022-03-21 11 findings Pillar5 Pharma Inc.Aseptic processing and sterility assurance · Contamination control · Deviation, CAPA, and investigation · Laboratory and QC controls · Labeling and packaging · Stability and storage · Computer system validation 2022-03-21 12 findings Olds Softgels Ltd.Validation and qualification · Equipment and facility · Complaint and recall handling · Stability and storage · Material and supplier control · Other quality system · Regulatory reporting and change control 2022-03-21 9 findings BWXT Medical Ltd.Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Other quality system 2022-03-21 9 findings Waymade Canada Inc.Regulatory reporting and change control · Deviation, CAPA, and investigation · Training and personnel · Equipment and facility 2022-03-21 4 findings MSS Ltd.Equipment and facility · Deviation, CAPA, and investigation · Stability and storage · Other quality system 2022-03-17 7 findings Pharmascience Inc.Material and supplier control · Other quality system · Cleaning validation · Training and personnel · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Complaint and recall handling · Equipment and facility 2022-03-16 15 findings Air Liquide Canada Inc.Computer system validation · Quality unit oversight · Deviation, CAPA, and investigation · Labeling and packaging 2022-03-15 4 findings The Avon Company Canada LimitedEquipment and facility · Laboratory and QC controls · Complaint and recall handling · Other quality system · Quality unit oversight · Stability and storage · Labeling and packaging · Material and supplier control · Deviation, CAPA, and investigation 2022-03-15 18 findings IMCD Canada LimitedEquipment and facility · Stability and storage · Other quality system · Labeling and packaging · Material and supplier control 2022-03-14 10 findings Sterinova IncDeviation, CAPA, and investigation · Other quality system · Material and supplier control 2022-03-14 5 findings Smith & Nephew Inc.Quality unit oversight · Training and personnel · Regulatory reporting and change control 2022-03-09 3 findings Emballages Spectrum Packaging Inc.Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Other quality system · Regulatory reporting and change control 2022-03-09 5 findings Cryogen Nitrogen Deliveries Ltd.Deviation, CAPA, and investigation · Laboratory and QC controls · Training and personnel · Other quality system · Equipment and facility 2022-03-09 7 findings Ostrem Chemical Co. Ltd.Complaint and recall handling · Other quality system · Regulatory reporting and change control · Stability and storage · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight 2022-03-08 11 findings Apotex IncAseptic processing and sterility assurance · Other quality system · Material and supplier control · Contamination control 2022-03-08 7 findings Lynden International Logistics ULCStability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls 2022-03-07 4 findings Laboratoire Lalco Inc.Material and supplier control · Laboratory and QC controls · Stability and storage · Other quality system · Regulatory reporting and change control · Equipment and facility · Quality unit oversight · Complaint and recall handling 2022-03-03 12 findings UniLab Analytical Services Inc.Other quality system · Equipment and facility · Computer system validation · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-03-02 5 findings Amorepacific Canada IncOther quality system · Regulatory reporting and change control · Quality unit oversight · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation 2022-03-02 6 findings Cosmetica Laboratories Inc.Stability and storage · Other quality system · Computer system validation · Equipment and facility 2022-03-01 5 findings Progress Therapeutics Inc.Complaint and recall handling · Quality unit oversight · Stability and storage · Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation 2022-03-01 6 findings WestRock Company of Canada Corp.Equipment and facility · Other quality system · Material and supplier control 2022-02-28 4 findings Lawson Health Research InstituteMaterial and supplier control · Laboratory and QC controls · Quality unit oversight · Complaint and recall handling · Other quality system · Computer system validation · Deviation, CAPA, and investigation 2022-02-28 8 findings Haemonetics Canada LtdLaboratory and QC controls · Deviation, CAPA, and investigation 2022-02-24 3 findings Agrisan Specialty Chemical & Pharmaceutical a division of Agrisan Inc.Contamination control · Equipment and facility · Other quality system · Validation and qualification · Deviation, CAPA, and investigation · Material and supplier control · Complaint and recall handling · Regulatory reporting and change control 2022-02-23 11 findings Euro-Pharm International Canada IncComputer system validation · Other quality system · Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Complaint and recall handling · Laboratory and QC controls · Quality unit oversight · Training and personnel · Regulatory reporting and change control · Labeling and packaging 2022-02-22 15 findings Eurofins EnvironeXDeviation, CAPA, and investigation · Other quality system 2022-02-21 5 findings Sivem Pharmaceuticals ULCOther quality system · Complaint and recall handling · Stability and storage 2022-02-21 5 findings N-Two Medical Inc.Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system · Laboratory and QC controls · Complaint and recall handling 2022-02-15 7 findings Apollo Health and Beauty CareOther quality system · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2022-02-15 6 findings Nu-Quest Distribution Inc.Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control · Complaint and recall handling 2022-02-15 4 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedStability and storage · Deviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control · Computer system validation · Validation and qualification · Aseptic processing and sterility assurance 2022-02-15 10 findings Taro Pharmaceuticals IncQuality unit oversight · Equipment and facility · Process validation · Deviation, CAPA, and investigation · Material and supplier control · Stability and storage 2022-02-14 8 findings Biomed PharmaOther quality system · Laboratory and QC controls · Stability and storage 2022-02-10 6 findings Chief Medical Supplies LtdEquipment and facility · Laboratory and QC controls · Material and supplier control · Validation and qualification · Other quality system · Stability and storage · Deviation, CAPA, and investigation · Cleaning validation · Computer system validation · Regulatory reporting and change control 2022-02-08 17 findings Imperial Distributors Canada Inc.Regulatory reporting and change control · Equipment and facility · Validation and qualification 2022-02-08 4 findings AMPAC Fine Chemicals Virginia, LLCRegulatory reporting and change control · Equipment and facility · Laboratory and QC controls 2022-02-07 4 findings Pfizer Inc.Computer system validation · Laboratory and QC controls · Deviation, CAPA, and investigation 2022-02-07 4 findings CTX Life Sciences Pvt. Ltd.Complaint and recall handling · Computer system validation · Labeling and packaging · Training and personnel · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system · Material and supplier control 2022-02-03 11 findings Bausch + Lomb CorporationOther quality system · Cleaning validation · Stability and storage 2022-02-02 4 findings Norrizon Sales & Marketing Group Inc.Other quality system · Equipment and facility · Material and supplier control 2022-02-02 4 findings Accord Healthcare Inc.Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight · Labeling and packaging · Other quality system 2022-02-02 8 findings Ranbaxy Pharmaceuticals Canada Inc. (a SUN PHARMA Company)Other quality system · Complaint and recall handling · Deviation, CAPA, and investigation 2022-02-01 6 findings Sun Pharma Canada Inc.Complaint and recall handling · Other quality system · Deviation, CAPA, and investigation 2022-02-01 6 findings Emergent BioSolutions Canada Inc.Regulatory reporting and change control · Other quality system 2022-01-27 3 findings Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc.Other quality system · Equipment and facility · Complaint and recall handling 2022-01-26 4 findings Apollo Health and Beauty CareOther quality system · Labeling and packaging · Stability and storage · Laboratory and QC controls · Validation and qualification 2022-01-25 7 findings West Penetone Inc.Stability and storage · Other quality system · Material and supplier control · Training and personnel · Laboratory and QC controls · Cleaning validation · Deviation, CAPA, and investigation · Complaint and recall handling · Contamination control · Equipment and facility · Computer system validation 2022-01-25 20 findings Universal Analytical Laboratories Inc.Other quality system · Computer system validation 2022-01-25 4 findings 2579364 Ontario Inc. (dba Pace Pharmacy)Other quality system · Stability and storage · Complaint and recall handling · Equipment and facility · Computer system validation 2022-01-25 5 findings ModernaTX, Inc.Other quality system · Regulatory reporting and change control · Deviation, CAPA, and investigation · Stability and storage · Laboratory and QC controls · Computer system validation 2022-01-25 11 findings Liberchem Inc.Laboratory and QC controls · Computer system validation · Other quality system · Cleaning validation · Stability and storage · Training and personnel · Equipment and facility · Contamination control · Material and supplier control 2022-01-24 11 findings Point 1 DisplaysEquipment and facility · Other quality system · Complaint and recall handling · Computer system validation 2022-01-24 6 findings Fusion Solution Inc.Other quality system · Deviation, CAPA, and investigation · Training and personnel · Computer system validation · Laboratory and QC controls · Validation and qualification · Material and supplier control 2022-01-21 11 findings LPG Inventory SolutionsStability and storage · Other quality system · Regulatory reporting and change control · Equipment and facility 2022-01-17 6 findings CSL Behring Canada Inc.Labeling and packaging · Other quality system · Regulatory reporting and change control · Deviation, CAPA, and investigation 2022-01-13 5 findings EGS EuroCamMaterial and supplier control · Laboratory and QC controls · Equipment and facility · Stability and storage · Computer system validation · Other quality system · Deviation, CAPA, and investigation · Validation and qualification 2022-01-11 16 findings Lonza Biologics Inc.Other quality system · Stability and storage · Computer system validation · Training and personnel · Deviation, CAPA, and investigation · Material and supplier control 2022-01-11 8 findings Teva Canada LimitedOther quality system · Regulatory reporting and change control · Complaint and recall handling · Stability and storage · Laboratory and QC controls 2022-01-10 6 findings