Areas cited
Other quality systemLaboratory and QC controlsDeviation, CAPA, and investigationComputer system validationRegulatory reporting and change controlEquipment and facilityAseptic processing and sterility assuranceStability and storageMaterial and supplier controlCleaning validationContamination control
Published inspection documents
2025-11-03
Health Canada
8 findingsEquipment and facility · Computer system validation · Regulatory reporting and change control · Laboratory and QC controls · Cleaning validation · Other quality system · Deviation, CAPA, and investigation The establishment and/or the maintenance of a data governance plan was inadequate. The maintenance of records was inadequate.
2024-11-12
Health Canada
13 findingsContamination control · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility · Aseptic processing and sterility assurance · Computer system validation The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination. The monitoring procedures for microbial and/or environmental conditions were inadequate.
2023-11-14
Health Canada
10 findingsDeviation, 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 The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2023-04-17
Health Canada
11 findingsStability 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 The ongoing stability program for a drug was 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.
