Firm Record
Apotex Inc findings history
79 findings from 14 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Equipment and facilityDeviation, CAPA, and investigationOther quality systemLaboratory and QC controlsMaterial and supplier controlAseptic processing and sterility assuranceComputer system validationStability and storageContamination controlProcess validationRegulatory reporting and change controlDocumentation and recordsComplaint and recall handlingCleaning validationLabeling and packagingQuality unit oversight
Published inspection documents
2026-04-13
Health Canada
5 findingsOther quality system · Equipment and facility · Documentation and records The handling of standard operating procedures for good manufacturing practices was inadequate.
2025-12-02
US FDA
10 findingsDeviation, CAPA, and investigation · Material and supplier control · Computer system validation · Aseptic processing and sterility assurance · Equipment and facility · Process validation · Laboratory and QC controls · Complaint and recall handling There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed.
2025-11-10
Health Canada
5 findingsOther quality system · Labeling and packaging · Laboratory and QC controls · Equipment and facility The assessment to release finished products was inadequate.
2025-11-04
US FDA
3 findingsAseptic processing and sterility assurance · Equipment and facility · Deviation, CAPA, and investigation Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Your firm also failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing…
2025-04-14
Health Canada
12 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Other quality system · Equipment and facility · Material and supplier control · Stability and storage · Cleaning validation The company's monitoring and documentation of heat sterilization cycles was inadequate.
2024-09-09
Health Canada
6 findingsLaboratory and QC controls · Deviation, CAPA, and investigation · Equipment and facility · Computer system validation · Material and supplier control The creation, maintenance, processing, and/or review of laboratory data was inadequate. The recorded information or details were inadequate.
2023-12-05
Health Canada
4 findingsEquipment and facility · Deviation, CAPA, and investigation · Laboratory and QC controls · Computer system validation The maintenance of records was inadequate.
2023-10-16
Health Canada
6 findingsEquipment and facility · Material and supplier control · Computer system validation · Aseptic processing and sterility assurance Evaluation of production processes, equipment, and/or materials was inadequate.
2023-02-14
Health Canada
8 findingsDeviation, CAPA, and investigation · Contamination control · Equipment and facility · Stability and storage · Computer system validation · Other quality system · Material and supplier control The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2023-01-16
Health Canada
4 findingsEquipment and facility · Quality unit oversight · Stability and storage The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080). The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
2023-01-16
Health Canada
3 findingsLaboratory and QC controls · Equipment and facility The creation, maintenance, processing, and/or review of laboratory data was inadequate.
2023-01-16
Health Canada
3 findingsOther quality system · Equipment and facility · Contamination control The assessment to release finished products was inadequate.
2022-03-08
Health Canada
7 findingsAseptic processing and sterility assurance · Other quality system · Material and supplier control · Contamination control In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
2021-01-11
Health Canada
3 findingsDeviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls Investigations into deviations, reports, and/or follow-up actions were inadequate.
About this page
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
