Health Canada · 2021

ConnectRX Inc.Stability and storage · Complaint and recall handling 2021-12-23 3 findings ConnectRX Inc.Stability and storage · Complaint and recall handling · Training and personnel 2021-12-20 4 findings ADV-Care Pharmacy Inc.Laboratory and QC controls · Other quality system · Stability and storage · Training and personnel · Equipment and facility 2021-12-14 7 findings Medison Pharma Canada Inc.Equipment and facility · Complaint and recall handling · Other quality system · Regulatory reporting and change control 2021-12-13 5 findings VPI Pharmaceuticals IncComplaint and recall handling · Stability and storage · Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Labeling and packaging 2021-12-13 11 findings Valeo Pharma IncLabeling and packaging · Stability and storage · Deviation, CAPA, and investigation · Other quality system · Complaint and recall handling · Regulatory reporting and change control 2021-12-13 10 findings Biocon LimitedComplaint and recall handling · Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Regulatory reporting and change control · Laboratory and QC controls 2021-12-12 9 findings Omega Laboratories Ltd. (now Juno Pharma Canada Inc.)Computer system validation · Other quality system · Stability and storage · Equipment and facility · Deviation, CAPA, and investigation 2021-12-07 5 findings Omega Laboratories Ltd. (now Juno Pharma Canada Inc.)Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Training and personnel · Equipment and facility · Stability and storage · Other quality system · Contamination control 2021-12-07 14 findings Omega Laboratories Ltd. (now Juno Pharma Canada Inc.)Computer system validation · Other quality system · Equipment and facility · Labeling and packaging · Contamination control 2021-12-07 8 findings Mantra Pharma Inc.Training and personnel · Other quality system · Stability and storage · Equipment and facility 2021-12-07 6 findings BC Cancer, part of the Provincial Health Services AuthorityLaboratory and QC controls · Equipment and facility 2021-12-07 3 findings EverZincMaterial and supplier control · Stability and storage · Documentation and records · Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control · Complaint and recall handling 2021-12-07 10 findings KVR Pharmaceuticals Inc.Other quality system · Training and personnel 2021-12-06 3 findings Strides Pharma Canada Inc.Material and supplier control · Equipment and facility · Complaint and recall handling · Labeling and packaging · Stability and storage · Training and personnel · Computer system validation 2021-12-06 7 findings Teva Canada LimitedEquipment and facility · Other quality system · Stability and storage · Cleaning validation 2021-12-06 6 findings Q-Pharm Inc.Complaint and recall handling · Training and personnel · Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Equipment and facility · Stability and storage 2021-12-06 8 findings Seagen Canada IncStability and storage · Labeling and packaging · Equipment and facility · Other quality system · Quality unit oversight · Regulatory reporting and change control · Deviation, CAPA, and investigation 2021-12-06 7 findings 2156684 Ontario Inc.Equipment and facility · Other quality system · Complaint and recall handling · Laboratory and QC controls · Stability and storage 2021-12-06 6 findings BLES Biochemicals IncOther quality system · Regulatory reporting and change control · Training and personnel · Deviation, CAPA, and investigation · Cleaning validation · Aseptic processing and sterility assurance · Equipment and facility · Stability and storage 2021-12-06 12 findings Stallergenes Canada Inc.Other quality system · Training and personnel · Equipment and facility · Laboratory and QC controls · Stability and storage · Regulatory reporting and change control · Deviation, CAPA, and investigation · Quality unit oversight 2021-12-01 12 findings Pharmascience Inc.Other quality system · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Material and supplier control · Computer system validation · Contamination control 2021-12-01 12 findings Microbios Analytique Inc.Deviation, CAPA, and investigation · Equipment and facility · Computer system validation · Labeling and packaging · Other quality system · Laboratory and QC controls 2021-12-01 7 findings Organon Canada Inc.Stability and storage · Complaint and recall handling · Deviation, CAPA, and investigation 2021-11-30 3 findings Globyz PharmaStability and storage · Other quality system · Laboratory and QC controls · Equipment and facility 2021-11-29 5 findings Dentsply Canada LimitedComplaint and recall handling · Regulatory reporting and change control · Stability and storage · Equipment and facility · Labeling and packaging 2021-11-24 8 findings DeLaval Inc.Material and supplier control · Equipment and facility · Laboratory and QC controls · Other quality system · Complaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Labeling and packaging · Training and personnel 2021-11-24 16 findings Alcon Canada IncComplaint and recall handling · Quality unit oversight · Regulatory reporting and change control · Stability and storage · Deviation, CAPA, and investigation · Other quality system · Labeling and packaging · Equipment and facility 2021-11-24 10 findings Aurium Pharma Inc.Other quality system · Complaint and recall handling · Laboratory and QC controls · Deviation, CAPA, and investigation · Stability and storage · Validation and qualification · Equipment and facility · Regulatory reporting and change control 2021-11-22 10 findings Trillium Health Care Products Inc.Stability and storage · Other quality system · Contamination control · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Documentation and records 2021-11-22 9 findings The Mentholatum Company of Canada LtdOther quality system · Stability and storage · Labeling and packaging · Laboratory and QC controls · Equipment and facility 2021-11-22 5 findings Lernapharm (Loris) Inc.Deviation, CAPA, and investigation · Cleaning validation · Equipment and facility · Other quality system · Quality unit oversight · Material and supplier control · Stability and storage · Computer system validation 2021-11-22 10 findings Alexion Pharma Canada CorpLaboratory and QC controls · Complaint and recall handling · Equipment and facility 2021-11-17 3 findings Zee Medical CanadaOther quality system · Quality unit oversight · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility 2021-11-17 8 findings BioScript Logistics Inc.Regulatory reporting and change control · Stability and storage 2021-11-16 3 findings Liebel-Flarsheim Canada Inc.Equipment and facility · Deviation, CAPA, and investigation · Labeling and packaging · Stability and storage · Laboratory and QC controls · Other quality system 2021-11-12 12 findings Bishara Pharma IncOther quality system · Computer system validation · Equipment and facility 2021-11-12 3 findings Hospira Inc.Contamination control · Laboratory and QC controls · Aseptic processing and sterility assurance · Other quality system · Computer system validation · Deviation, CAPA, and investigation 2021-11-08 8 findings International Nutrient Technologies LimitedDeviation, CAPA, and investigation · Equipment and facility · Other quality system · Contamination control · Labeling and packaging 2021-11-08 5 findings Delpharm Boucherville Canada Inc.Deviation, CAPA, and investigation · Stability and storage · Equipment and facility · Computer system validation 2021-11-08 5 findings Delpharm Boucherville Canada Inc.Other quality system · Contamination control · Labeling and packaging · Quality unit oversight · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation · Stability and storage 2021-11-08 16 findings Novocol Pharmaceutical of Canada Inc.Other quality system · Laboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Deviation, CAPA, and investigation · Stability and storage 2021-11-08 10 findings Diteba Laboratories Inc.Training and personnel · Equipment and facility · Laboratory and QC controls · Material and supplier control · Deviation, CAPA, and investigation · Regulatory reporting and change control 2021-11-01 8 findings Elvium Life SciencesQuality unit oversight · Other quality system · Stability and storage 2021-11-01 5 findings Factors Group of Nutritional Companies Inc.Cleaning validation · Laboratory and QC controls · Other quality system · Material and supplier control · Labeling and packaging · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation 2021-10-26 11 findings Pathogenia Inc.Other quality system · Laboratory and QC controls · Computer system validation · Equipment and facility · Stability and storage 2021-10-26 7 findings Hain-Celestial Canada, ULCStability and storage · Training and personnel · Other quality system 2021-10-26 3 findings Activation Laboratories LtdLaboratory and QC controls · Equipment and facility · Stability and storage · Regulatory reporting and change control · Deviation, CAPA, and investigation · Other quality system 2021-10-25 9 findings Emergent Manufacturing Operations Baltimore, LLCOther quality system · Laboratory and QC controls · Equipment and facility · Computer system validation · Deviation, CAPA, and investigation · Regulatory reporting and change control 2021-10-25 11 findings Groupe Dissan Inc.Laboratory and QC controls · Other quality system · Material and supplier control · Quality unit oversight · Equipment and facility · Stability and storage · Deviation, CAPA, and investigation · Training and personnel 2021-10-19 13 findings Medisca Pharmaceutique Inc.Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Complaint and recall handling · Stability and storage 2021-10-18 6 findings Medisca Pharmaceutique Inc.Other quality system · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control · Equipment and facility · Laboratory and QC controls · Complaint and recall handling 2021-10-18 9 findings Air Liquide Canada Inc.Laboratory and QC controls · Training and personnel · Other quality system 2021-10-18 5 findings Canadian Blood ServicesComplaint and recall handling · Material and supplier control · Training and personnel · Other quality system · Deviation, CAPA, and investigation 2021-10-18 8 findings Andone Pharmaceutical IncDeviation, CAPA, and investigation · Other quality system · Equipment and facility · Complaint and recall handling · Stability and storage · Laboratory and QC controls · Quality unit oversight 2021-10-18 10 findings Kenvue Canada Inc.Equipment and facility · Laboratory and QC controls · Labeling and packaging · Deviation, CAPA, and investigation · Material and supplier control 2021-10-18 8 findings Ontario Home Oxygen And Respiratory Service Inc.Other quality system · Computer system validation · Quality unit oversight 2021-10-13 4 findings Deluxe Health Group Inc.Equipment and facility · Regulatory reporting and change control · Computer system validation · Other quality system · Deviation, CAPA, and investigation 2021-10-13 5 findings ProResp Inc.Equipment and facility · Other quality system · Computer system validation 2021-10-13 3 findings Steri-Med Pharma Inc.Aseptic processing and sterility assurance · Laboratory and QC controls · Contamination control · Training and personnel · Stability and storage · Deviation, CAPA, and investigation · Other quality system · Equipment and facility · Material and supplier control 2021-10-12 18 findings Jubilant Hollisterstier General PartnershipDeviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance · Contamination control · Computer system validation 2021-10-12 6 findings Dalton Chemical Laboratories Inc. O/A Dalton Pharma ServicesContamination control · Aseptic processing and sterility assurance · Material and supplier control · Equipment and facility · Other quality system · Regulatory reporting and change control · Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls 2021-10-05 17 findings Factors Group of Nutritional Companies Inc.Deviation, CAPA, and investigation · Contamination control · Equipment and facility · Other quality system · Material and supplier control · Computer system validation · Laboratory and QC controls · Documentation and records · Regulatory reporting and change control 2021-10-05 16 findings 11916530 CANADA LIMITED dba Pharmore GlobalEquipment and facility · Complaint and recall handling · Training and personnel · Stability and storage 2021-10-05 4 findings Genvion CorporationOther quality system · Laboratory and QC controls 2021-09-29 3 findings Pharmalab Inc. (now JAMP Manufacturing Inc.)Contamination control · Quality unit oversight · Deviation, CAPA, and investigation · Equipment and facility · Labeling and packaging · Stability and storage 2021-09-28 8 findings Baxter CorporationOther quality system · Material and supplier control · Laboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Computer system validation · Regulatory reporting and change control 2021-09-27 11 findings H & A Canada Inc. c/o Pharmrite North America Corp.Training and personnel · Equipment and facility · Stability and storage · Complaint and recall handling · Labeling and packaging · Other quality system 2021-09-27 10 findings Chief Medical Supplies LtdComplaint and recall handling · Other quality system · Labeling and packaging · Regulatory reporting and change control · Cleaning validation 2021-09-23 8 findings Gurvey & Berry Co. Inc.Training and personnel · Stability and storage · Equipment and facility · Regulatory reporting and change control 2021-09-22 4 findings Macco Organiques IncDeviation, CAPA, and investigation · Regulatory reporting and change control · Stability and storage · Computer system validation · Other quality system · Material and supplier control · Labeling and packaging · Equipment and facility · Laboratory and QC controls 2021-09-20 14 findings Thunder Bay Regional Health Sciences CentreAseptic processing and sterility assurance · Other quality system · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Computer system validation 2021-09-20 9 findings The Shandex Sales Group LimitedLaboratory and QC controls · Stability and storage · Quality unit oversight · Equipment and facility 2021-09-16 5 findings Univar Solutions Canada Ltd.Other quality system · Material and supplier control · Equipment and facility · Training and personnel · Stability and storage 2021-09-16 5 findings Long Wing International, Inc.Other quality system · Equipment and facility · Stability and storage 2021-09-15 4 findings Les Emballages Façoteck Inc.Regulatory reporting and change control · Complaint and recall handling · Cleaning validation · Equipment and facility · Material and supplier control · Stability and storage · Deviation, CAPA, and investigation · Other quality system 2021-09-13 11 findings Laboratoire Léo Désilets M.H. Inc.Complaint and recall handling · Regulatory reporting and change control · Material and supplier control · Stability and storage · Other quality system 2021-09-13 5 findings Sterinova IncOther quality system · Equipment and facility · Laboratory and QC controls · Computer system validation 2021-09-13 4 findings Germiphene CorporationLabeling and packaging · Material and supplier control · Laboratory and QC controls · Stability and storage · Computer system validation · Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control 2021-09-13 13 findings 1641252 Alberta Ltd. DBA WhiteOpEquipment and facility · Complaint and recall handling · Stability and storage 2021-09-13 5 findings Opella Canada Inc.Other quality system · Laboratory and QC controls · Complaint and recall handling · Labeling and packaging · Stability and storage · Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility 2021-09-13 9 findings Coloplast Canada CorporationOther quality system · Validation and qualification · Deviation, CAPA, and investigation · Quality unit oversight · Stability and storage 2021-09-08 6 findings Abbott Laboratories Co.Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls 2021-09-07 3 findings Inoca Healthcare Inc.Stability and storage · Equipment and facility · Other quality system 2021-09-07 4 findings VitalAire Canada IncEquipment and facility · Regulatory reporting and change control · Labeling and packaging 2021-08-31 3 findings Medline Canada CorporationOther quality system · Labeling and packaging · Validation and qualification · Equipment and facility · Complaint and recall handling 2021-08-26 7 findings NUCM Radiopharma Inc.Complaint and recall handling · Deviation, CAPA, and investigation · Laboratory and QC controls · Other quality system · Computer system validation · Equipment and facility 2021-08-23 10 findings Centre De Recherche Sur Les Biotechnologies Marines (CRBM)Other quality system · Equipment and facility · Labeling and packaging · Computer system validation · Deviation, CAPA, and investigation 2021-08-23 6 findings Laboratoire Atlas Inc.Other quality system · Stability and storage · Material and supplier control · Cleaning validation · Labeling and packaging · Equipment and facility 2021-08-23 9 findings Empack Spraytech Inc.Regulatory reporting and change control · Other quality system · Complaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls 2021-08-23 11 findings Laboval Inc.Regulatory reporting and change control · Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Computer system validation 2021-08-16 9 findings Haleon Canada ULCComplaint and recall handling · Deviation, CAPA, and investigation · Stability and storage 2021-08-16 3 findings Lupin Pharma Canada LimitedEquipment and facility · Labeling and packaging · Other quality system · Quality unit oversight · Complaint and recall handling 2021-08-10 5 findings Charles Tennant & Co (Canada) Ltd.Equipment and facility · Other quality system · Stability and storage · Deviation, CAPA, and investigation · Training and personnel 2021-08-09 10 findings Liberchem Inc.Other quality system · Laboratory and QC controls · Regulatory reporting and change control · Stability and storage · Quality unit oversight · Equipment and facility · Labeling and packaging · Material and supplier control 2021-08-09 10 findings Cellchem Pharmaceuticals Inc.Complaint and recall handling · Quality unit oversight · Laboratory and QC controls · Stability and storage · Material and supplier control · Deviation, CAPA, and investigation · Equipment and facility · Other quality system · Regulatory reporting and change control 2021-08-03 10 findings Isologic Innovative Radiopharmaceuticals Ltd.Other quality system · Equipment and facility · Contamination control · Laboratory and QC controls · Deviation, CAPA, and investigation · Computer system validation 2021-08-03 7 findings PCCA CorpDeviation, CAPA, and investigation · Labeling and packaging · Stability and storage · Other quality system · Regulatory reporting and change control 2021-08-03 5 findings MNK Recherches Inc.Stability and storage · Computer system validation · Regulatory reporting and change control · Equipment and facility · Laboratory and QC controls · Other quality system · Quality unit oversight 2021-08-03 7 findings ID Biomedical Corporation of QuebecEquipment and facility · Other quality system · Computer system validation · Laboratory and QC controls · Deviation, CAPA, and investigation 2021-08-02 6 findings AX Pharmaceutical CorpOther quality system · Complaint and recall handling · Labeling and packaging · Laboratory and QC controls · Computer system validation · Quality unit oversight · Stability and storage · Deviation, CAPA, and investigation · Contamination control 2021-07-29 14 findings Occy Laboratoire Inc.Other quality system · Laboratory and QC controls · Material and supplier control · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility 2021-07-27 10 findings Vita Bee Health Canada Ltd.Labeling and packaging · Complaint and recall handling · Other quality system · Stability and storage · Validation and qualification · Equipment and facility · Regulatory reporting and change control · Laboratory and QC controls 2021-07-26 9 findings BioVectra IncDeviation, CAPA, and investigation · Other quality system · Computer system validation · Equipment and facility · Laboratory and QC controls 2021-07-26 7 findings Wright Hand Packaging Inc.Equipment and facility · Regulatory reporting and change control · Other quality system 2021-07-26 3 findings Patris Holdings LtdDeviation, CAPA, and investigation · Material and supplier control · Stability and storage · Equipment and facility · Other quality system · Computer system validation · Validation and qualification · Quality unit oversight · Cleaning validation 2021-07-19 19 findings AccuristixRegulatory reporting and change control · Quality unit oversight · Material and supplier control · Computer system validation · Other quality system · Complaint and recall handling · Equipment and facility · Deviation, CAPA, and investigation 2021-07-19 9 findings Pachem Distribution Inc.Other quality system · Stability and storage · Regulatory reporting and change control · Training and personnel · Laboratory and QC controls · Labeling and packaging · Complaint and recall handling 2021-07-14 9 findings Diagnostic Imaging, Nova Scotia Health AuthorityOther quality system · Aseptic processing and sterility assurance · Contamination control · Laboratory and QC controls · Stability and storage 2021-07-12 7 findings Medicago Inc.Laboratory and QC controls · Stability and storage · Other quality system 2021-07-07 4 findings Ccrest Laboratories Inc.Other quality system · Computer system validation · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Training and personnel 2021-07-07 10 findings Clarins Canada Inc.Equipment and facility · Computer system validation · Other quality system · Regulatory reporting and change control · Deviation, CAPA, and investigation 2021-07-06 7 findings Hansamed LimitedOther quality system · Stability and storage · Equipment and facility · Complaint and recall handling · Regulatory reporting and change control · Deviation, CAPA, and investigation · Labeling and packaging 2021-07-06 13 findings Brenntag Canada Inc.Laboratory and QC controls · Stability and storage · Equipment and facility · Other quality system · Computer system validation 2021-06-24 7 findings Rusan Pharma Canada Inc.Complaint and recall handling · Equipment and facility · Other quality system · Regulatory reporting and change control 2021-06-22 7 findings Genix Pharmaceuticals CorporationComputer system validation · Equipment and facility · Other quality system 2021-06-22 3 findings J.L. Freeman S.E.C.Deviation, CAPA, and investigation · Stability and storage · Labeling and packaging · Other quality system 2021-06-15 6 findings Lynden International Logistics ULCDeviation, CAPA, and investigation · Training and personnel · Equipment and facility 2021-06-14 3 findings Pro Doc LimitéeEquipment and facility · Other quality system · Deviation, CAPA, and investigation · Stability and storage · Quality unit oversight · Complaint and recall handling · Material and supplier control 2021-06-14 16 findings Voyant Beauty, Inc.Stability and storage · Other quality system · Regulatory reporting and change control · Equipment and facility · Deviation, CAPA, and investigation 2021-06-14 6 findings Voyant Beauty, Inc.Stability and storage · Other quality system · Quality unit oversight · Laboratory and QC controls · Labeling and packaging · Deviation, CAPA, and investigation · Equipment and facility · Regulatory reporting and change control 2021-06-14 11 findings Voyant Beauty, Inc.Equipment and facility · Regulatory reporting and change control · Other quality system · Deviation, CAPA, and investigation · Stability and storage 2021-06-14 6 findings Voyant Beauty, Inc.Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control · Stability and storage · Material and supplier control · Laboratory and QC controls 2021-06-14 9 findings Voyant Beauty, Inc.Other quality system · Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Regulatory reporting and change control · Laboratory and QC controls 2021-06-14 9 findings ViiV Healthcare ULCComplaint and recall handling · Deviation, CAPA, and investigation · Other quality system 2021-06-14 3 findings GlaxoSmithKline Inc.Complaint and recall handling · Other quality system · Deviation, CAPA, and investigation 2021-06-14 4 findings GlaxoSmithKline Inc.Stability and storage · Other quality system · Labeling and packaging · Deviation, CAPA, and investigation 2021-06-14 4 findings Procter & Gamble IncOther quality system · Computer system validation · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls 2021-06-14 5 findings Astellas Pharma Canada IncEquipment and facility · Stability and storage · Other quality system 2021-06-10 5 findings Labomar Canada Inc.Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Other quality system · Equipment and facility · Contamination control 2021-06-10 10 findings Capcium Inc.Training and personnel · Validation and qualification · Other quality system · Computer system validation · Labeling and packaging · Laboratory and QC controls · Equipment and facility · Stability and storage 2021-06-07 10 findings Alpha Laboratories Inc.Laboratory and QC controls · Deviation, CAPA, and investigation · Other quality system · Regulatory reporting and change control 2021-06-07 6 findings Imperial Distributors Canada Inc.Other quality system · Regulatory reporting and change control · Stability and storage 2021-05-31 7 findings Almat Pharmachem Inc.Other quality system · Stability and storage · Equipment and facility · Regulatory reporting and change control · Deviation, CAPA, and investigation · Quality unit oversight · Labeling and packaging · Laboratory and QC controls · Complaint and recall handling 2021-05-31 12 findings Canadian Molecular Imaging Probe Consortium (CanProbe)Computer system validation · Aseptic processing and sterility assurance · Other quality system 2021-05-31 4 findings Dufort & Lavigne LtéeStability and storage · Other quality system · Equipment and facility · Validation and qualification 2021-05-28 5 findings Neopharm LavalDeviation, CAPA, and investigation · Laboratory and QC controls · Other quality system · Computer system validation 2021-05-28 5 findings Alembic Pharmaceuticals Canada LtdOther quality system · Equipment and facility · Laboratory and QC controls 2021-05-28 3 findings Arthropharm Pharmaceuticals Inc.Other quality system · Material and supplier control · Equipment and facility · Complaint and recall handling · Regulatory reporting and change control · Laboratory and QC controls · Stability and storage · Labeling and packaging 2021-05-27 15 findings Isologic Innovative Radiopharmaceuticals Ltd.Deviation, CAPA, and investigation · Stability and storage · Equipment and facility · Aseptic processing and sterility assurance · Computer system validation · Laboratory and QC controls 2021-05-25 7 findings Groupe Parima Inc.Other quality system · Stability and storage · Laboratory and QC controls · Equipment and facility · Complaint and recall handling · Deviation, CAPA, and investigation 2021-05-21 7 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedOther quality system · Complaint and recall handling · Deviation, CAPA, and investigation · Stability and storage 2021-05-18 6 findings Groupe Marcelle Inc.Training and personnel · Equipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Computer system validation · Complaint and recall handling · Regulatory reporting and change control · Other quality system · Stability and storage 2021-05-17 11 findings Co-Pak Packaging CorpLaboratory and QC controls · Stability and storage · Labeling and packaging 2021-05-17 4 findings MediPharm Labs Inc.Other quality system · Equipment and facility · Complaint and recall handling 2021-05-12 4 findings Angita Pharma Inc.Deviation, CAPA, and investigation · Equipment and facility · Other quality system 2021-05-10 3 findings Jamp Pharma CorporationOther quality system · Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Regulatory reporting and change control 2021-05-10 8 findings Centre Hospitalier Universitaire de SherbrookeComputer system validation · Equipment and facility · Aseptic processing and sterility assurance · Stability and storage · Other quality system 2021-05-10 7 findings Galenova Inc.Labeling and packaging · Validation and qualification · Stability and storage · Other quality system · Deviation, CAPA, and investigation 2021-05-10 7 findings H.J. Sutton Industries Ltd.Stability and storage · Labeling and packaging · Other quality system · Regulatory reporting and change control 2021-05-05 7 findings GasPro, division of ProResp Inc.Other quality system · Regulatory reporting and change control · Equipment and facility 2021-05-05 4 findings PBG BioPharma Inc.Other quality system · Labeling and packaging · Deviation, CAPA, and investigation · Computer system validation · Laboratory and QC controls · Regulatory reporting and change control · Equipment and facility · Training and personnel 2021-05-04 12 findings Dr. Reddy's Laboratories Canada IncLabeling and packaging · Other quality system · Complaint and recall handling · Equipment and facility · Regulatory reporting and change control · Stability and storage · Quality unit oversight · Deviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls 2021-05-03 15 findings Nutrimmune Technologies IncorporatedLaboratory and QC controls · Regulatory reporting and change control · Other quality system · Stability and storage · Complaint and recall handling · Deviation, CAPA, and investigation · Equipment and facility 2021-04-28 8 findings Janssen IncLaboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Other quality system 2021-04-27 5 findings Dermolab Pharma LtéeDeviation, CAPA, and investigation · Laboratory and QC controls · Training and personnel · Other quality system · Stability and storage 2021-04-22 8 findings Lynden International Logistics ULCStability and storage · Complaint and recall handling · Equipment and facility 2021-04-22 3 findings PCI Pharma Services Canada, Inc.Deviation, CAPA, and investigation · Other quality system 2021-04-21 3 findings Famar Montréal Inc.Equipment and facility · Complaint and recall handling · Laboratory and QC controls · Contamination control · Material and supplier control 2021-04-19 6 findings Delta Pharma Inc.Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Stability and storage · Complaint and recall handling · Material and supplier control · Regulatory reporting and change control · Cleaning validation 2021-04-19 11 findings Medicago Inc.Deviation, CAPA, and investigation · Stability and storage · Laboratory and QC controls · Computer system validation · Other quality system 2021-04-19 6 findings Delta Pharma Inc.Equipment and facility · Computer system validation · Material and supplier control · Cleaning validation · Laboratory and QC controls · Other quality system · Complaint and recall handling · Stability and storage · Deviation, CAPA, and investigation · Regulatory reporting and change control 2021-04-19 14 findings Investigative Science IncorporatedOther quality system · Laboratory and QC controls · Equipment and facility · Training and personnel · Deviation, CAPA, and investigation 2021-04-19 5 findings Endoceutics Pharma (MSH) Inc.Laboratory and QC controls · Validation and qualification · Complaint and recall handling · Material and supplier control · Other quality system · Deviation, CAPA, and investigation · Cleaning validation 2021-04-19 8 findings Delpharm Montréal Inc.Contamination control · Laboratory and QC controls · Equipment and facility · Complaint and recall handling · Material and supplier control 2021-04-19 6 findings LabofineOther quality system · Stability and storage · Equipment and facility · Computer system validation 2021-04-19 7 findings Les Entreprises Azurtech (9089-4395 Quebec Inc.)Computer system validation · Equipment and facility · Stability and storage · Other quality system · Deviation, CAPA, and investigation 2021-04-14 6 findings Carestream Medical ULC dba MedPro Respiratory CareOther quality system · Regulatory reporting and change control · Training and personnel 2021-04-12 4 findings Accel Pharma IncOther quality system · Stability and storage · Complaint and recall handling · Labeling and packaging · Laboratory and QC controls · Equipment and facility 2021-04-12 9 findings 12719924 Canada Ltd.Other quality system · Material and supplier control · Stability and storage 2021-04-08 3 findings Medicago USA Inc.Other quality system · Cleaning validation · Stability and storage · Material and supplier control · Computer system validation 2021-04-06 11 findings Medicago USA Inc.Laboratory and QC controls · Other quality system 2021-04-06 3 findings Toronto General Hospital, University Health NetworkEquipment and facility · Other quality system · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation 2021-03-31 6 findings HK Kolmar Canada, Inc.Complaint and recall handling · Quality unit oversight · Other quality system · Equipment and facility · Laboratory and QC controls · Training and personnel · Stability and storage · Deviation, CAPA, and investigation · Cleaning validation · Computer system validation · Regulatory reporting and change control 2021-03-29 22 findings Athena Canada Inc.Other quality system · Complaint and recall handling · Labeling and packaging · Stability and storage · Laboratory and QC controls 2021-03-29 6 findings Duchesnay Inc.Cleaning validation · Material and supplier control · Other quality system · Equipment and facility · Stability and storage 2021-03-29 5 findings Euro-Pharm International Canada IncOther quality system · Equipment and facility · Training and personnel · Stability and storage 2021-03-23 6 findings British Columbia Centre for Disease Control and Prevention Society BranchLaboratory and QC controls · Complaint and recall handling · Material and supplier control · Training and personnel · Computer system validation · Other quality system · Stability and storage 2021-03-11 8 findings British Columbia Centre for Disease Control and Prevention Society BranchLaboratory and QC controls · Material and supplier control · Complaint and recall handling · Training and personnel · Computer system validation · Other quality system · Stability and storage 2021-03-11 8 findings Ropack Inc.Stability and storage · Deviation, CAPA, and investigation · Cleaning validation · Other quality system · Equipment and facility 2021-03-11 5 findings Ropack Inc.Complaint and recall handling · Equipment and facility · Labeling and packaging · Stability and storage · Deviation, CAPA, and investigation · Cleaning validation 2021-03-11 7 findings Shiseido Canada Inc.Regulatory reporting and change control · Training and personnel · Other quality system 2021-03-10 3 findings Fillab Inc.Complaint and recall handling · Other quality system · Regulatory reporting and change control · Deviation, CAPA, and investigation · Training and personnel · Labeling and packaging · Computer system validation 2021-03-10 7 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedAseptic processing and sterility assurance · Labeling and packaging · Training and personnel · Stability and storage · Complaint and recall handling · Other quality system 2021-03-08 9 findings Contract Pharmaceuticals Limited CanadaRegulatory reporting and change control · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Quality unit oversight 2021-03-04 10 findings Apotex Pharmachem Inc.Equipment and facility · Laboratory and QC controls · Regulatory reporting and change control · Stability and storage · Other quality system · Labeling and packaging · Material and supplier control · Deviation, CAPA, and investigation · Complaint and recall handling 2021-03-03 12 findings Sterimax IncRegulatory reporting and change control · Deviation, CAPA, and investigation · Equipment and facility · Stability and storage · Other quality system · Labeling and packaging · Complaint and recall handling · Quality unit oversight 2021-03-03 15 findings Isologic Innovative Radiopharmaceuticals Ltd.Material and supplier control · Aseptic processing and sterility assurance · Other quality system · Equipment and facility · Validation and qualification · Deviation, CAPA, and investigation · Complaint and recall handling · Stability and storage · Laboratory and QC controls 2021-03-01 12 findings Fresenius Kabi Canada Ltd.Laboratory and QC controls · Quality unit oversight · Equipment and facility · Complaint and recall handling 2021-02-25 5 findings E-Z-EM Canada Inc.Validation and qualification · Computer system validation · Cleaning validation · Deviation, CAPA, and investigation · Other quality system · Stability and storage · Regulatory reporting and change control 2021-02-18 8 findings Haemotec, a division of Fresenius Medical Care Canada Inc.Labeling and packaging · Cleaning validation · Material and supplier control 2021-02-16 4 findings Quantum Pharma IncOther quality system · Contamination control · Computer system validation 2021-02-16 6 findings Odan Laboratories Ltd.Equipment and facility · Computer system validation · Material and supplier control · Deviation, CAPA, and investigation · Stability and storage · Cleaning validation · Complaint and recall handling 2021-02-15 11 findings Sciences de la Peau Crescita Inc. / Crescita Skin Sciences Inc.Equipment and facility · Other quality system · Deviation, CAPA, and investigation · Cleaning validation · Complaint and recall handling · Laboratory and QC controls · Stability and storage · Validation and qualification 2021-02-10 12 findings Bora Pharmaceutical Services Inc.Other quality system · Deviation, CAPA, and investigation 2021-02-09 6 findings Isologic Innovative Radiopharmaceuticals of Ontario LimitedOther quality system · Computer system validation · Material and supplier control · Laboratory and QC controls · Equipment and facility · Deviation, CAPA, and investigation · Stability and storage 2021-02-08 8 findings Jubilant Draximage Inc. dba Jubilant RadiopharmaCleaning validation · Deviation, CAPA, and investigation · Other quality system · Computer system validation · Training and personnel · Equipment and facility · Stability and storage 2021-02-08 9 findings Jones Healthcare Group Packaging Services Inc.Regulatory reporting and change control · Other quality system · Laboratory and QC controls · Deviation, CAPA, and investigation · Complaint and recall handling · Computer system validation · Equipment and facility 2021-02-08 8 findings Element Materials Technology Life Sciences Canada Inc.Equipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation 2021-02-08 4 findings Methapharm IncStability and storage · Labeling and packaging · Other quality system · Complaint and recall handling · Regulatory reporting and change control · Equipment and facility · Deviation, CAPA, and investigation 2021-02-02 14 findings Natural Active Ingredients Inc.Training and personnel · Laboratory and QC controls · Other quality system · Equipment and facility · Complaint and recall handling 2021-01-28 5 findings Nuvo Pharmaceuticals Inc.Training and personnel · Stability and storage · Other quality system 2021-01-25 4 findings Previmed Inc.Other quality system · Labeling and packaging · Complaint and recall handling 2021-01-20 3 findings Nordion (Canada) Inc.Other quality system · Training and personnel · Equipment and facility · Deviation, CAPA, and investigation · Computer system validation 2021-01-20 6 findings Patheon Inc.Contamination control · Deviation, CAPA, and investigation · Computer system validation 2021-01-18 4 findings Atlas Pharma Inc.Computer system validation · Other quality system · Equipment and facility · Deviation, CAPA, and investigation · Regulatory reporting and change control 2021-01-18 6 findings Air Liquide Canada Inc.Other quality system · Quality unit oversight · Equipment and facility · Laboratory and QC controls · Regulatory reporting and change control 2021-01-13 9 findings Le Groupe UltrapacOther quality system · Training and personnel · Deviation, CAPA, and investigation · Stability and storage · Quality unit oversight · Computer system validation · Material and supplier control · Equipment and facility · Regulatory reporting and change control · Cleaning validation 2021-01-12 20 findings Barentz Canada ULCOther quality system · Labeling and packaging · Equipment and facility 2021-01-12 3 findings Apotex IncDeviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls 2021-01-11 3 findings Ani Pharmaceuticals Canada Inc.Quality unit oversight · Labeling and packaging · Equipment and facility · Other quality system · Deviation, CAPA, and investigation 2021-01-11 8 findings Montreal Neurological InstituteOther quality system · Computer system validation · Deviation, CAPA, and investigation · Equipment and facility · Laboratory and QC controls · Aseptic processing and sterility assurance · Complaint and recall handling 2021-01-11 11 findings