Areas cited
Other quality systemEquipment and facilityDeviation, CAPA, and investigationAseptic processing and sterility assuranceTraining and personnelStability and storageMaterial and supplier controlComputer system validationDocumentation and recordsComplaint and recall handlingCleaning validationLaboratory and QC controlsContamination controlLabeling and packagingQuality unit oversight
Published inspection documents
2025-03-20
Health Canada
8 findingsDocumentation and records · Deviation, CAPA, and investigation · Equipment and facility · Aseptic processing and sterility assurance · Other quality system As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
2024-01-22
Health Canada
12 findingsOther quality system · Equipment and facility · Deviation, CAPA, and investigation · Computer system validation · Stability and storage · Quality unit oversight The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
2023-03-21
Health Canada
6 findingsOther quality system · Aseptic processing and sterility assurance · Training and personnel The written clothing standards for each environmental grade were inadequate.
2022-03-16
Health Canada
15 findingsMaterial and supplier control · Other quality system · Cleaning validation · Training and personnel · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Complaint and recall handling · Equipment and facility Yields and/or the reconciled quantities were not checked at appropriate stages. The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
2021-12-01
Health Canada
12 findingsOther 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 The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions 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.
