Areas cited
Other quality systemComplaint and recall handlingStability and storageDeviation, CAPA, and investigationEquipment and facilityMaterial and supplier controlRegulatory reporting and change controlLaboratory and QC controls
Published inspection documents
2024-01-30
Health Canada
5 findingsStability and storage · Other quality system · Deviation, CAPA, and investigation · Material and supplier control · Complaint and recall handling The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
2024-01-30
Health Canada
5 findingsStability and storage · Material and supplier control · Complaint and recall handling · Deviation, CAPA, and investigation · Other quality system The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .
2021-10-18
Health Canada
6 findingsEquipment and facility · Other quality system · Deviation, CAPA, and investigation · Complaint and recall handling · Stability and storage The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
2021-10-18
Health Canada
9 findingsOther 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 The master production documents 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.
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