Health Canada · 2023

Verity Pharmaceuticals Inc.Quality unit oversight · Complaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system 2023-12-19 7 findings Distribution 2LG inc.Regulatory reporting and change control · Laboratory and QC controls · Stability and storage · Computer system validation 2023-12-18 5 findings Pathogenia Inc.Laboratory and QC controls · Regulatory reporting and change control · Contamination control · Equipment and facility · Computer system validation 2023-12-13 6 findings Professional Disposables International LtdDeviation, CAPA, and investigation · Quality unit oversight · Equipment and facility · Stability and storage 2023-12-12 4 findings Acerus Pharmaceuticals CorporationEquipment and facility · Complaint and recall handling · Regulatory reporting and change control · Other quality system · Material and supplier control 2023-12-12 6 findings CB Medical Inc.Equipment and facility · Stability and storage · Laboratory and QC controls 2023-12-12 4 findings BC Cancer, part of the Provincial Health Services AuthorityOther quality system · Complaint and recall handling · Material and supplier control · Laboratory and QC controls 2023-12-11 7 findings Eurofins CDMO Alphora IncorporatedOther quality system · Laboratory and QC controls · Equipment and facility 2023-12-11 7 findings Takeda Pharmaceutical Company LimitedDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Other quality system 2023-12-11 4 findings Bausch & Lomb Inc.Aseptic processing and sterility assurance · Equipment and facility · Material and supplier control · Contamination control · Other quality system · Laboratory and QC controls · Computer system validation · Cleaning validation · Stability and storage 2023-12-11 16 findings CDMV Inc.Complaint and recall handling · Deviation, CAPA, and investigation · Other quality system · Validation and qualification · Equipment and facility · Stability and storage 2023-12-07 9 findings Atlas Pharma Inc.Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Training and personnel · Laboratory and QC controls · Equipment and facility · Computer system validation 2023-12-05 9 findings Apotex IncEquipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Computer system validation 2023-12-05 4 findings 2253500 Alberta Inc.Other quality system · Material and supplier control · Complaint and recall handling · Stability and storage · Validation and qualification · Computer system validation · Cleaning validation · Deviation, CAPA, and investigation 2023-12-05 11 findings Duchesnay Inc.Contamination control · Other quality system · Equipment and facility 2023-12-04 3 findings Air Liquide Canada Inc.Equipment and facility · Other quality system · Cleaning validation · Regulatory reporting and change control 2023-12-04 5 findings Air Liquide Canada Inc.Other quality system · Regulatory reporting and change control · Cleaning validation · Equipment and facility 2023-12-04 5 findings Air Liquide Canada Inc.Regulatory reporting and change control · Equipment and facility · Cleaning validation · Other quality system 2023-12-04 5 findings Air Liquide Canada Inc.Regulatory reporting and change control · Cleaning validation · Equipment and facility · Other quality system 2023-12-04 5 findings Air Liquide Canada Inc.Regulatory reporting and change control · Other quality system · Cleaning validation · Equipment and facility 2023-12-04 5 findings Air Liquide Canada Inc.Other quality system · Equipment and facility · Regulatory reporting and change control · Cleaning validation 2023-12-04 5 findings Air Liquide Canada Inc.Equipment and facility · Cleaning validation · Regulatory reporting and change control · Other quality system 2023-12-04 5 findings Air Liquide Canada Inc.Equipment and facility · Cleaning validation · Other quality system · Regulatory reporting and change control 2023-12-04 5 findings Primera Analytical Solutions Corp.Stability and storage · Regulatory reporting and change control · Laboratory and QC controls · Contamination control · Equipment and facility · Material and supplier control · Deviation, CAPA, and investigation · Other quality system 2023-12-04 9 findings Primera Analytical Solutions Corp.Equipment and facility · Stability and storage · Other quality system · Regulatory reporting and change control · Contamination control · Material and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls 2023-12-04 9 findings Canada Medical LtdStability and storage · Other quality system · Deviation, CAPA, and investigation 2023-11-28 4 findings ANVO Pharma Inc.Equipment and facility · Deviation, CAPA, and investigation · Complaint and recall handling · Laboratory and QC controls · Other quality system · Regulatory reporting and change control · Stability and storage 2023-11-28 8 findings Laboratoire Lalco Inc.Other quality system · Equipment and facility · Laboratory and QC controls · Quality unit oversight 2023-11-15 6 findings Thea Pharma, IncStability and storage · Deviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control · Other quality system · Complaint and recall handling 2023-11-15 6 findings Biolyse Pharma CorporationDeviation, CAPA, and investigation · Regulatory reporting and change control · Material and supplier control · Laboratory and QC controls · Equipment and facility · Other quality system · Computer system validation 2023-11-14 10 findings ILS Pharma IncTraining and personnel · Computer system validation · Equipment and facility 2023-11-14 4 findings Searchlight Pharma IncQuality unit oversight · Other quality system · Complaint and recall handling 2023-11-14 4 findings Factors Group of Nutritional Companies Inc.Regulatory reporting and change control · Other quality system · Equipment and facility · Material and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls 2023-11-14 8 findings Ropack Inc.Other quality system · Laboratory and QC controls · Material and supplier control · Labeling and packaging 2023-11-06 6 findings Steri-Med Pharma Inc.Aseptic processing and sterility assurance · Other quality system · Material and supplier control · Regulatory reporting and change control · Equipment and facility · Deviation, CAPA, and investigation 2023-11-06 10 findings NUCM Radiopharma Inc.Aseptic processing and sterility assurance · Other quality system · Cleaning validation · Deviation, CAPA, and investigation · Laboratory and QC controls · Computer system validation · Stability and storage · Regulatory reporting and change control · Complaint and recall handling 2023-11-06 15 findings 2450524 Ontario Inc. DBA Glen Shields PharmacyOther quality system · Stability and storage 2023-11-02 3 findings Oral Science Inc.Equipment and facility · Complaint and recall handling · Other quality system · Laboratory and QC controls · Regulatory reporting and change control · Quality unit oversight 2023-10-31 9 findings Isologic Innovative Radiopharmaceuticals Ltd.Stability and storage · Laboratory and QC controls · Equipment and facility 2023-10-31 3 findings Winnipeg Regional Health AuthorityDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Training and personnel 2023-10-30 9 findings Novocol Pharmaceutical of Canada Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Contamination control · Material and supplier control 2023-10-26 5 findings Kohl & Frisch LimitedDeviation, CAPA, and investigation · Other quality system · Training and personnel 2023-10-24 3 findings Novocol Pharmaceutical of Canada Inc.Contamination control · Equipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Other quality system 2023-10-23 7 findings Lawson Health Research InstituteOther quality system · Cleaning validation · Training and personnel · Contamination control 2023-10-23 5 findings Sumitomo Pharma Canada, Inc.Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system 2023-10-23 3 findings Ichor Inc.Other quality system · Stability and storage · Cleaning validation · Equipment and facility 2023-10-23 8 findings Factors Group of Nutritional Companies Inc.Material and supplier control · Computer system validation · Documentation and records · Regulatory reporting and change control · Other quality system · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2023-10-23 11 findings TJP Labs Inc.Stability and storage · Material and supplier control · Cleaning validation · Validation and qualification · Regulatory reporting and change control · Computer system validation 2023-10-18 8 findings EverZincLaboratory and QC controls · Equipment and facility · Stability and storage · Complaint and recall handling · Deviation, CAPA, and investigation 2023-10-16 8 findings Aralez Pharmaceuticals Canada Inc.Laboratory and QC controls · Other quality system · Quality unit oversight · Regulatory reporting and change control · Stability and storage 2023-10-16 8 findings Mid East Canadian Pharmaceutical IncMaterial and supplier control · Stability and storage · Other quality system · Laboratory and QC controls 2023-10-16 5 findings Apotex IncEquipment and facility · Material and supplier control · Computer system validation · Aseptic processing and sterility assurance 2023-10-16 6 findings Nephron Pharmaceuticals CorporationEquipment and facility · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Material and supplier control · Other quality system · Laboratory and QC controls · Cleaning validation · Training and personnel 2023-10-16 16 findings Stryker Canada ULCEquipment and facility · Other quality system · Complaint and recall handling 2023-10-11 5 findings Cerapie Pharma Inc.Equipment and facility · Other quality system · Computer system validation · Stability and storage · Material and supplier control 2023-10-10 6 findings VitalAire Canada IncLaboratory and QC controls · Equipment and facility · Complaint and recall handling · Other quality system · Quality unit oversight · Deviation, CAPA, and investigation · Regulatory reporting and change control 2023-10-04 11 findings Galenova Inc.Complaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation · Validation and qualification · Other quality system · Computer system validation · Training and personnel · Laboratory and QC controls 2023-10-03 10 findings ACI Brands Inc.Training and personnel · Other quality system · Material and supplier control · Stability and storage · Equipment and facility 2023-10-03 6 findings Formative Pharma Inc.Computer system validation · Regulatory reporting and change control · Stability and storage 2023-10-03 3 findings Xediton Pharmaceuticals IncOther quality system · Regulatory reporting and change control · Quality unit oversight 2023-09-28 3 findings Delmar Chemicals Inc./Les Produits Chimiques Delmar Inc.Deviation, CAPA, and investigation · Equipment and facility · Cleaning validation · Other quality system · Material and supplier control · Training and personnel · Computer system validation · Complaint and recall handling 2023-09-26 9 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedOther quality system · Equipment and facility 2023-09-19 3 findings Edgewell Personal Care Canada, ULCStability and storage · Other quality system · Deviation, CAPA, and investigation · Material and supplier control · Regulatory reporting and change control 2023-09-19 7 findings 1201258 Ontario Inc O/A Nanz PharmaOther quality system · Computer system validation · Equipment and facility 2023-09-14 6 findings Sava Healthcare Ltd.Computer system validation · Other quality system 2023-09-14 4 findings Air Liquide Canada Inc.Equipment and facility · Other quality system · Regulatory reporting and change control · Deviation, CAPA, and investigation · Computer system validation 2023-09-12 5 findings Altea Farmaceutica SAEquipment and facility · Cleaning validation · Laboratory and QC controls · Material and supplier control 2023-09-11 5 findings Baxter CorporationOther quality system · Aseptic processing and sterility assurance · Equipment and facility · Laboratory and QC controls · Training and personnel · Material and supplier control · Contamination control 2023-09-11 12 findings Meridian Medical Technologies, LLCDeviation, CAPA, and investigation · Other quality system · Aseptic processing and sterility assurance 2023-09-11 4 findings Piramal Pharma LimitedCleaning validation · Other quality system · Material and supplier control · Equipment and facility · Training and personnel 2023-09-11 6 findings University Health Network Radiotheranostics CoreLaboratory and QC controls · Cleaning validation · Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control · Equipment and facility · Material and supplier control · Computer system validation 2023-09-11 12 findings Omega Laboratories Ltd. (now Juno Pharma Canada Inc.)Aseptic processing and sterility assurance · Computer system validation · Contamination control · Other quality system · Equipment and facility · Laboratory and QC controls · Regulatory reporting and change control 2023-09-07 12 findings Omega Laboratories Ltd. (now Juno Pharma Canada Inc.)Material and supplier control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls 2023-09-07 4 findings Héma-QuébecEquipment and facility · Complaint and recall handling · Deviation, CAPA, and investigation 2023-09-07 3 findings Kimberly-Clark IncOther quality system · Deviation, CAPA, and investigation · Equipment and facility 2023-09-06 3 findings Norrizon Sales & Marketing Group Inc.Equipment and facility · Labeling and packaging · Other quality system 2023-09-06 3 findings 10152825 Manitoba Ltd.Stability and storage · Training and personnel · Computer system validation 2023-08-31 4 findings VitalAire Canada IncRegulatory reporting and change control · Equipment and facility · Training and personnel · Other quality system · Laboratory and QC controls 2023-08-29 5 findings McRina Laboratories Inc.Other quality system · Equipment and facility · Training and personnel 2023-08-28 3 findings Global Analytical Laboratories Inc.Other quality system · Contamination control · Training and personnel · Computer system validation 2023-08-28 5 findings WILC Healthcare Inc.Other quality system · Complaint and recall handling · Stability and storage · Training and personnel · Quality unit oversight 2023-08-23 6 findings Hugel Canada Inc.Other quality system · Training and personnel · Complaint and recall handling · Laboratory and QC controls 2023-08-22 5 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system 2023-08-21 6 findings Quimica Canada LimitedStability and storage · Other quality system · Equipment and facility · Labeling and packaging 2023-08-21 5 findings Classic Health Supplies LtdOther quality system · Deviation, CAPA, and investigation · Stability and storage 2023-08-15 3 findings WG Pro-Manufacturing Inc.Cleaning validation · Laboratory and QC controls · Other quality system 2023-08-15 4 findings Ontario Medical Supply Inc.Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls · Equipment and facility 2023-08-15 5 findings Aqualitas Inc.Cleaning validation · Equipment and facility · Other quality system · Stability and storage 2023-08-14 4 findings Delta Plus Canada Inc.Quality unit oversight · Other quality system · Material and supplier control · Stability and storage · Laboratory and QC controls · Regulatory reporting and change control 2023-08-09 8 findings PLZ Corp.Other quality system 2023-08-08 3 findings Metro Supply Chain Solutions Inc.Labeling and packaging · Quality unit oversight · Regulatory reporting and change control · Deviation, CAPA, and investigation · Other quality system · Cleaning validation · Equipment and facility 2023-08-08 7 findings Allerquest LLCDeviation, CAPA, and investigation · Complaint and recall handling · Cleaning validation · Other quality system · Laboratory and QC controls 2023-08-07 7 findings GenMed, a division of Pfizer Canada ULCOther quality system · Laboratory and QC controls · Complaint and recall handling · Stability and storage 2023-08-07 4 findings Pfizer Canada ULCComplaint and recall handling · Deviation, CAPA, and investigation · Labeling and packaging · Equipment and facility · Laboratory and QC controls 2023-08-07 7 findings Shiseido Canada Inc.Computer system validation · Other quality system · Equipment and facility · Regulatory reporting and change control · Deviation, CAPA, and investigation 2023-08-02 6 findings imRex Inc.Regulatory reporting and change control · Equipment and facility · Complaint and recall handling · Other quality system · Stability and storage 2023-08-01 6 findings AbbVie Inc.Other quality system · Equipment and facility 2023-08-01 3 findings MediPharm Labs Inc.Computer system validation · Laboratory and QC controls · Other quality system · Documentation and records · Regulatory reporting and change control · Deviation, CAPA, and investigation 2023-07-31 7 findings LEC Custom Products Inc.Other quality system · Stability and storage · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls · Complaint and recall handling · Material and supplier control · Cleaning validation · Training and personnel 2023-07-31 17 findings Shields Pharma Inc.Other quality system · Computer system validation · Equipment and facility · Contamination control 2023-07-25 5 findings Beauty Mark Solutions IncLabeling and packaging · Equipment and facility · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Stability and storage · Regulatory reporting and change control · Quality unit oversight · Material and supplier control 2023-07-25 16 findings Diagnostic Imaging, Nova Scotia Health AuthorityOther quality system · Laboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Regulatory reporting and change control 2023-07-24 12 findings British Columbia Centre for Disease Control and Prevention Society BranchComplaint and recall handling · Training and personnel · Stability and storage 2023-07-20 4 findings AbbVie CorporationStability and storage · Equipment and facility · Complaint and recall handling · Deviation, CAPA, and investigation · Other quality system 2023-07-18 6 findings AMD Medicom Inc.Equipment and facility · Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation 2023-07-17 5 findings Intervet Canada Corp.Deviation, CAPA, and investigation · Complaint and recall handling · Regulatory reporting and change control 2023-07-17 3 findings Merck Canada IncOther quality system · Laboratory and QC controls · Complaint and recall handling 2023-07-17 3 findings Quality Chemical Laboratories, LLCOther quality system · Laboratory and QC controls 2023-07-11 3 findings Dermtek Pharma Inc.Training and personnel · Deviation, CAPA, and investigation · Computer system validation · Material and supplier control · Complaint and recall handling · Equipment and facility · Quality unit oversight · Other quality system · Regulatory reporting and change control · Stability and storage 2023-07-11 16 findings Accelera Pharma Canada Inc. doing business as APCIOther quality system · Equipment and facility · Stability and storage · Laboratory and QC controls 2023-07-04 5 findings Air Liquide Canada Inc.Other quality system · Equipment and facility · Regulatory reporting and change control · Complaint and recall handling · Training and personnel 2023-07-04 5 findings Pillar5 Pharma Inc.Other quality system · Labeling and packaging 2023-06-28 4 findings Mary Kay Cosmetics LtdRegulatory reporting and change control · Other quality system · Stability and storage · Equipment and facility · Quality unit oversight 2023-06-27 7 findings Sun Pharmaceutical Industries LimitedMaterial and supplier control · Computer system validation · Equipment and facility 2023-06-26 3 findings Eugia Pharma Specialities LimitedMaterial and supplier control · Aseptic processing and sterility assurance · Cleaning validation · Equipment and facility · Laboratory and QC controls · Other quality system 2023-06-26 7 findings Isologic Innovative Radiopharmaceuticals Ltd.Equipment and facility · Stability and storage · Other quality system · Computer system validation · Deviation, CAPA, and investigation 2023-06-20 6 findings Dalton Chemical Laboratories Inc. O/A Dalton Pharma ServicesOther quality system · Labeling and packaging · Deviation, CAPA, and investigation · Computer system validation · Aseptic processing and sterility assurance · Material and supplier control 2023-06-20 9 findings Drucan Trading Corp.Computer system validation · Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Complaint and recall handling 2023-06-20 8 findings SGS Canada Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation 2023-06-20 6 findings Prestilux Inc.Stability and storage · Regulatory reporting and change control · Complaint and recall handling · Quality unit oversight · Equipment and facility · Training and personnel 2023-06-19 7 findings Natco Pharma LimitedDeviation, CAPA, and investigation · Contamination control · Regulatory reporting and change control · Stability and storage · Equipment and facility · Other quality system · Computer system validation 2023-06-19 7 findings Natco Pharma LimitedContamination control · Stability and storage · Deviation, CAPA, and investigation · Computer system validation · Other quality system 2023-06-19 5 findings PolyPeptide Laboratories Pvt LtdMaterial and supplier control · Computer system validation · Cleaning validation 2023-06-19 4 findings Ortho Biologics LLCOther quality system · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Cleaning validation 2023-06-19 6 findings Purdue PharmaComplaint and recall handling · Other quality system · Training and personnel · Computer system validation · Equipment and facility 2023-06-19 6 findings Convatec Canada Ltd.Training and personnel · Complaint and recall handling · Laboratory and QC controls 2023-06-14 3 findings AstraZeneca Canada Inc.Other quality system · Quality unit oversight · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation 2023-06-12 8 findings BioMarin Pharmaceutical (Canada) IncEquipment and facility · Training and personnel · Other quality system 2023-06-12 4 findings Air Liquide Canada Inc.Training and personnel · Quality unit oversight · Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Laboratory and QC controls 2023-06-08 6 findings KJK Pharmacy Inc.Material and supplier control · Other quality system · Stability and storage 2023-06-07 3 findings Empack Spraytech Inc.Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control · Other quality system · Computer system validation · Cleaning validation 2023-06-07 10 findings Novartis Pharmaceuticals Canada IncOther quality system · Complaint and recall handling · Regulatory reporting and change control 2023-06-07 3 findings McCaughey Consumer Products Management, Inc.Other quality system · Stability and storage · Training and personnel 2023-06-06 4 findings Bausch + Lomb CorporationEquipment and facility · Regulatory reporting and change control · Deviation, CAPA, and investigation 2023-06-06 3 findings Merck Sharp & Dohme LLCEquipment and facility · Complaint and recall handling · Other quality system · Stability and storage · Material and supplier control · Cleaning validation 2023-06-05 7 findings Curia Wisconsin Inc.Computer system validation · Contamination control · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Labeling and packaging 2023-06-05 7 findings Centre Hospitalier Universitaire de SherbrookeEquipment and facility · Computer system validation · Other quality system · Complaint and recall handling · Aseptic processing and sterility assurance · Environmental monitoring 2023-06-05 6 findings Alera Skin Care Products Inc.Complaint and recall handling · Other quality system · Stability and storage · Quality unit oversight · Laboratory and QC controls · Regulatory reporting and change control · Equipment and facility 2023-06-05 11 findings Servier Canada IncComplaint and recall handling · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system 2023-05-31 6 findings Messer Canada Inc.Regulatory reporting and change control · Deviation, CAPA, and investigation · Other quality system · Complaint and recall handling 2023-05-31 5 findings RGR Pharma Ltd.Laboratory and QC controls · Equipment and facility · Other quality system · Labeling and packaging 2023-05-30 8 findings Columbia Laboratories Canada Inc.Regulatory reporting and change control · Other quality system · Deviation, CAPA, and investigation 2023-05-30 5 findings Dr. Reddy's Laboratories LimitedComplaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Material and supplier control 2023-05-29 5 findings Quantipharm Inc.Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Computer system validation 2023-05-23 5 findings Novocol Pharmaceutical of Canada Inc.Other quality system · Validation and qualification · Contamination control 2023-05-23 3 findings AA Pharma Inc.Deviation, CAPA, and investigation · Complaint and recall handling 2023-05-23 3 findings Beiersdorf Canada IncComplaint and recall handling · Other quality system · Laboratory and QC controls · Equipment and facility · Regulatory reporting and change control · Deviation, CAPA, and investigation 2023-05-16 8 findings Sigma Life Sciences Inc.Computer system validation · Equipment and facility · Labeling and packaging · Other quality system · Stability and storage · Deviation, CAPA, and investigation 2023-05-15 8 findings Edmonton Radiopharmaceutical Centre (Alberta Health Services)Other quality system · Equipment and facility · Regulatory reporting and change control · Computer system validation 2023-05-15 6 findings Linde Canada Inc.Material and supplier control · Equipment and facility · Quality unit oversight 2023-05-11 3 findings Mantra Pharma Inc.Laboratory and QC controls · Other quality system · Stability and storage · Deviation, CAPA, and investigation 2023-05-10 4 findings Linde Canada Inc.Equipment and facility · Quality unit oversight · Material and supplier control 2023-05-10 3 findings Generic Medical Partners IncRegulatory reporting and change control · Stability and storage · Complaint and recall handling · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation 2023-05-08 10 findings Kohl & Frisch LimitedLaboratory and QC controls · Equipment and facility · Training and personnel · Deviation, CAPA, and investigation 2023-05-08 4 findings PHL Distributions Inc.Equipment and facility · Stability and storage · Other quality system · Laboratory and QC controls 2023-05-03 6 findings Lantheus MI Canada IncTraining and personnel · Complaint and recall handling · Other quality system 2023-05-03 4 findings TJP Labs Inc.Equipment and facility · Labeling and packaging · Material and supplier control · Laboratory and QC controls · Contamination control · Stability and storage · Other quality system · Computer system validation · Documentation and records · Regulatory reporting and change control 2023-05-02 13 findings Sterinova IncStability and storage · Contamination control · Aseptic processing and sterility assurance · Computer system validation 2023-05-01 4 findings Capcium Inc.Deviation, CAPA, and investigation · Stability and storage · Laboratory and QC controls · Other quality system · Labeling and packaging · Computer system validation · Equipment and facility · Cleaning validation 2023-05-01 10 findings HYTN Cannabis Inc.Material and supplier control · Documentation and records · Stability and storage · Equipment and facility · Other quality system · Laboratory and QC controls · Computer system validation · Cleaning validation · Deviation, CAPA, and investigation 2023-05-01 16 findings Arthropharm Pharmaceuticals Inc.Stability and storage · Other quality system · Equipment and facility · Regulatory reporting and change control 2023-04-25 5 findings Blistex CorporationDeviation, CAPA, and investigation · Regulatory reporting and change control · Labeling and packaging · Equipment and facility · Other quality system · Complaint and recall handling 2023-04-25 6 findings Procter & Gamble IncOther quality system · Equipment and facility · Laboratory and QC controls · Stability and storage 2023-04-20 4 findings The Avon Company Canada LimitedEquipment and facility · Material and supplier control · Other quality system · Stability and storage · Regulatory reporting and change control · Deviation, CAPA, and investigation 2023-04-18 7 findings Henkel Canada CorporationMaterial and supplier control · Equipment and facility · Other quality system · Regulatory reporting and change control · Complaint and recall handling · Deviation, CAPA, and investigation · Quality unit oversight · Stability and storage 2023-04-17 11 findings Biolyse Pharma CorporationStability and storage · Material and supplier control · Deviation, CAPA, and investigation · Computer system validation · Regulatory reporting and change control · Aseptic processing and sterility assurance · Other quality system · Laboratory and QC controls 2023-04-17 11 findings Mackenzie Drug MartStability and storage · Other quality system 2023-04-14 3 findings Cryogen Nitrogen Deliveries Ltd.Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility 2023-04-11 3 findings Chief Medical Supplies LtdMaterial and supplier control · Other quality system · Stability and storage · Equipment and facility · Laboratory and QC controls · Training and personnel · Quality unit oversight · Deviation, CAPA, and investigation · Labeling and packaging · Computer system validation · Contamination control 2023-04-11 19 findings Toronto General Hospital, University Health NetworkDeviation, CAPA, and investigation · Stability and storage · Other quality system · Complaint and recall handling · Cleaning validation 2023-04-11 5 findings Y.S.P. Industries (M) Sdn. Bhd.Contamination control · Other quality system · Equipment and facility · Labeling and packaging · Laboratory and QC controls · Computer system validation · Deviation, CAPA, and investigation · Stability and storage 2023-04-06 12 findings 2579364 Ontario Inc. (dba Pace Pharmacy)Equipment and facility · Stability and storage · Training and personnel · Other quality system 2023-04-05 5 findings Samsung Bioepis Co., Ltd.Other quality system · Computer system validation 2023-04-03 3 findings Le Groupe Jean Coutu (PJC) Inc.Equipment and facility · Other quality system · Training and personnel 2023-03-29 5 findings Eisai LimitedStability and storage · Other quality system · Equipment and facility · Labeling and packaging · Training and personnel · Deviation, CAPA, and investigation 2023-03-29 10 findings Medicine Place Inc.Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Labeling and packaging · Other quality system · Stability and storage · Complaint and recall handling 2023-03-28 12 findings Bausch Health Companies Inc.Deviation, CAPA, and investigation · Other quality system · Computer system validation · Training and personnel 2023-03-28 4 findings Pharma Importing Inc.Other quality system · Regulatory reporting and change control · Stability and storage 2023-03-28 5 findings Messer Canada Inc.Training and personnel · Regulatory reporting and change control · Other quality system 2023-03-28 3 findings IMCD Canada LimitedOther quality system · Equipment and facility · Stability and storage · Material and supplier control 2023-03-28 6 findings 1000098888 Ontario Inc.Other quality system · Equipment and facility · Training and personnel · Stability and storage 2023-03-22 5 findings 10445517 Canada Inc / North Pharmaceuticals / DAC PharmaceuticalsLabeling and packaging · Laboratory and QC controls · Equipment and facility 2023-03-22 5 findings Sanofi Vaccines Canada Ltd.Other quality system · Computer system validation · Deviation, CAPA, and investigation 2023-03-21 3 findings Pharmascience Inc.Other quality system · Aseptic processing and sterility assurance · Training and personnel 2023-03-21 6 findings Biogen Canada IncStability and storage · Other quality system · Complaint and recall handling · Regulatory reporting and change control · Equipment and facility 2023-03-21 6 findings Health Partners International of CanadaEquipment and facility · Stability and storage · Regulatory reporting and change control · Other quality system · Material and supplier control · Deviation, CAPA, and investigation 2023-03-21 8 findings CDMV Inc.Training and personnel · Regulatory reporting and change control · Other quality system · Stability and storage · Equipment and facility 2023-03-21 6 findings McKesson Canada CorporationComputer system validation · Equipment and facility · Other quality system · Laboratory and QC controls · Complaint and recall handling 2023-03-15 5 findings Eurofins CDMO Alphora IncorporatedLaboratory and QC controls · Equipment and facility · Computer system validation 2023-03-15 5 findings INNOVA Medical Ophthalmics Inc.Equipment and facility · Labeling and packaging · Stability and storage · Complaint and recall handling · Other quality system · Laboratory and QC controls 2023-03-13 6 findings Innomar Strategies IncLabeling and packaging · Regulatory reporting and change control · Other quality system · Equipment and facility · Complaint and recall handling 2023-03-13 7 findings Air Liquide Canada Inc.Laboratory and QC controls · Equipment and facility · Other quality system · Computer system validation · Deviation, CAPA, and investigation · Material and supplier control · Quality unit oversight · Regulatory reporting and change control 2023-03-13 12 findings Lupin LimitedMaterial and supplier control · Cleaning validation · Equipment and facility · Quality unit oversight · Deviation, CAPA, and investigation · Complaint and recall handling 2023-03-13 8 findings Galentic Pharma India Pvt, LtdAseptic processing and sterility assurance · Stability and storage · Other quality system 2023-03-13 3 findings Lupin LimitedOther quality system · Regulatory reporting and change control · Stability and storage · Equipment and facility 2023-03-09 4 findings ZO Skin Health Canada ULCEquipment and facility · Stability and storage · Laboratory and QC controls · Other quality system · Computer system validation 2023-03-09 7 findings Moderna Biopharma Canada CorporationOther quality system · Labeling and packaging · Stability and storage · Complaint and recall handling 2023-03-08 4 findings AbbVie CorporationTraining and personnel · Stability and storage · Other quality system 2023-03-08 3 findings Wockhardt Uk Ltd.Equipment and facility · Other quality system · Stability and storage 2023-03-07 3 findings A & C American Chemicals Ltd.Laboratory and QC controls · Material and supplier control · Other quality system · Complaint and recall handling · Validation and qualification · Deviation, CAPA, and investigation · Computer system validation 2023-03-07 10 findings Pendopharm, Division of Pharmascience IncDeviation, CAPA, and investigation · Other quality system · Complaint and recall handling 2023-03-07 5 findings Contract Pharmaceuticals Limited CanadaComputer system validation · Deviation, CAPA, and investigation · Material and supplier control · Equipment and facility · Other quality system 2023-03-06 5 findings ICU Medical Inc.Other quality system · Equipment and facility · Quality unit oversight · Computer system validation · Deviation, CAPA, and investigation · Cleaning validation · Laboratory and QC controls · Regulatory reporting and change control · Material and supplier control 2023-03-06 12 findings Leadiant Biosciences, Inc.Complaint and recall handling · Quality unit oversight · Equipment and facility · Deviation, CAPA, and investigation · Other quality system 2023-03-01 6 findings Amgen Canada IncDeviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Other quality system 2023-03-01 5 findings VitalAire Canada IncComplaint and recall handling · Equipment and facility · Other quality system · Regulatory reporting and change control · Laboratory and QC controls 2023-02-28 5 findings Rodan & Fields Canada, ULCOther quality system · Stability and storage 2023-02-27 3 findings HUMN Pharmaceuticals Inc.Quality unit oversight · Stability and storage · Other quality system 2023-02-23 4 findings Xenex Laboratories Inc.Regulatory reporting and change control · Other quality system · Stability and storage · Quality unit oversight · Material and supplier control · Labeling and packaging 2023-02-22 6 findings West Penetone Inc.Equipment and facility · Other quality system · Complaint and recall handling · Stability and storage · Laboratory and QC controls · Computer system validation · Material and supplier control 2023-02-21 12 findings PLZ Corp.Labeling and packaging · Laboratory and QC controls · Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Validation and qualification · Regulatory reporting and change control · Contamination control · Computer system validation 2023-02-21 15 findings Microbios Analytique Inc.Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation · Computer system validation 2023-02-21 4 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedComplaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Computer system validation · Labeling and packaging · Equipment and facility · Aseptic processing and sterility assurance · Other quality system 2023-02-20 9 findings ID Biomedical Corporation of QuebecDeviation, CAPA, and investigation · Other quality system · Equipment and facility · Computer system validation 2023-02-20 5 findings Neilmed Pharmaceuticals IncLabeling and packaging · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Computer system validation 2023-02-15 9 findings Apotex IncDeviation, CAPA, and investigation · Contamination control · Equipment and facility · Stability and storage · Computer system validation · Other quality system · Material and supplier control 2023-02-14 8 findings Novo Nordisk Canada IncComplaint and recall handling · Laboratory and QC controls · Stability and storage · Training and personnel · Deviation, CAPA, and investigation 2023-02-13 8 findings Atul Bioscience Ltd.Cleaning validation · Stability and storage · Laboratory and QC controls · Labeling and packaging · Equipment and facility · Other quality system 2023-02-13 8 findings uniPHARM Wholesale Drugs Ltd.Regulatory reporting and change control · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Stability and storage 2023-02-08 5 findings Novel Biome Solutions Inc.Laboratory and QC controls · Other quality system · Computer system validation · Equipment and facility · Contamination control · Validation and qualification · Material and supplier control 2023-02-08 16 findings Cipher Pharmaceuticals Inc.Equipment and facility · Complaint and recall handling 2023-02-07 4 findings Bayer IncOther quality system · Material and supplier control · Equipment and facility · Complaint and recall handling · Computer system validation · Deviation, CAPA, and investigation 2023-02-07 14 findings Chief Medical Supplies LtdOther quality system · Material and supplier control · Regulatory reporting and change control · Training and personnel · Computer system validation · Laboratory and QC controls 2023-02-06 9 findings GE Healthcare Canada Inc.Laboratory and QC controls · Other quality system · Stability and storage · Regulatory reporting and change control 2023-02-06 7 findings Pioneer Agro IndustriesEquipment and facility · Other quality system · Validation and qualification · Laboratory and QC controls · Computer system validation · Stability and storage 2023-02-06 10 findings Isologic Innovative Radiopharmaceuticals Ltd.Aseptic processing and sterility assurance · Computer system validation · Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Quality unit oversight · Other quality system 2023-02-06 10 findings VitalAire Canada IncLaboratory and QC controls · Other quality system · Training and personnel 2023-02-02 5 findings Nordion (Canada) Inc.Complaint and recall handling · Laboratory and QC controls · Equipment and facility · Labeling and packaging · Training and personnel 2023-02-01 6 findings ConnectRX Inc.Equipment and facility · Other quality system · Regulatory reporting and change control · Stability and storage · Deviation, CAPA, and investigation 2023-02-01 7 findings SUN Pharmaceutical Medicare Limited (SPML)Other quality system · Aseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation 2023-01-30 8 findings Enviro-Health Research Laboratories Inc.Equipment and facility · Other quality system · Computer system validation · Laboratory and QC controls · Complaint and recall handling · Regulatory reporting and change control 2023-01-25 8 findings Pancap Pharma Inc.Other quality system · Laboratory and QC controls · Material and supplier control · Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Training and personnel · Labeling and packaging 2023-01-24 13 findings Jubilant Draximage Inc. dba Jubilant RadiopharmaOther quality system · Equipment and facility · Deviation, CAPA, and investigation · Stability and storage · Labeling and packaging · Quality unit oversight · Complaint and recall handling 2023-01-23 10 findings 11916530 CANADA LIMITED dba Pharmore GlobalContamination control · Stability and storage · Equipment and facility · Other quality system 2023-01-23 5 findings Lallemand Health Solutions Inc./Lallemand Solutions Santé Inc.Deviation, CAPA, and investigation · Contamination control · Regulatory reporting and change control · Computer system validation · Other quality system · Material and supplier control · Equipment and facility · Complaint and recall handling 2023-01-23 9 findings Pharmaris Canada Inc.Other quality system · Regulatory reporting and change control · Computer system validation · Quality unit oversight · Validation and qualification 2023-01-19 6 findings Leda Health Innovations Inc.Labeling and packaging · Other quality system · Stability and storage · Training and personnel · Deviation, CAPA, and investigation · Equipment and facility 2023-01-17 7 findings Erfa Canada 2012 IncStability and storage · Laboratory and QC controls · Complaint and recall handling 2023-01-16 3 findings Apotex IncEquipment and facility · Quality unit oversight · Stability and storage 2023-01-16 4 findings Apotex IncLaboratory and QC controls · Equipment and facility 2023-01-16 3 findings Apotex IncOther quality system · Equipment and facility · Contamination control 2023-01-16 3 findings Mint Pharmaceuticals IncDeviation, CAPA, and investigation · Labeling and packaging · Stability and storage 2023-01-16 3 findings McGuff Medical Canada Inc.Stability and storage · Regulatory reporting and change control · Laboratory and QC controls · Deviation, CAPA, and investigation 2023-01-12 4 findings SGS Canada Inc.Equipment and facility · Other quality system · Laboratory and QC controls 2023-01-11 4 findings Express Scripts Canada WholesaleOther quality system · Stability and storage · Complaint and recall handling · Deviation, CAPA, and investigation · Regulatory reporting and change control · Equipment and facility 2023-01-10 8 findings Linde Canada Inc.Cleaning validation · Deviation, CAPA, and investigation · Equipment and facility 2023-01-10 3 findings Pancap Pharma Inc.Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control · Computer system validation 2023-01-10 11 findings Macleods Pharmaceuticals LimitedContamination control · Regulatory reporting and change control · Cleaning validation · Deviation, CAPA, and investigation · Equipment and facility · Other quality system 2023-01-09 7 findings