Areas cited
Other quality systemEquipment and facilityLaboratory and QC controlsStability and storageMaterial and supplier controlComputer system validationComplaint and recall handlingCleaning validationDeviation, CAPA, and investigationTraining and personnelRegulatory reporting and change controlContamination control
Published inspection documents
2025-03-05
Health Canada
14 findingsRegulatory reporting and change control · Cleaning validation · Stability and storage · Deviation, CAPA, and investigation · Material and supplier control · Laboratory and QC controls · Other quality system · Computer system validation · Equipment and facility The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
2023-02-21
Health Canada
12 findingsEquipment and facility · Other quality system · Complaint and recall handling · Stability and storage · Laboratory and QC controls · Computer system validation · Material and supplier control The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
2022-01-25
Health Canada
20 findingsStability and storage · Other quality system · Material and supplier control · Training and personnel · Laboratory and QC controls · Cleaning validation · Deviation, CAPA, and investigation · Complaint and recall handling · Contamination control · Equipment and facility · Computer system validation The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
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.
