Areas cited
Other quality systemEquipment and facilityAseptic processing and sterility assuranceDeviation, CAPA, and investigationTraining and personnelMaterial and supplier controlValidation and qualificationCleaning validationLaboratory and QC controlsStability and storageContamination controlComputer system validationQuality unit oversight
Published inspection documents
2026-05-11
Health Canada
9 findingsOther quality system · Material and supplier control · Equipment and facility · Aseptic processing and sterility assurance · Training and personnel · Computer system validation The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
2024-11-18
Health Canada
6 findingsOther quality system · Cleaning validation · Validation and qualification · Training and personnel · Deviation, CAPA, and investigation · Equipment and facility The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
2024-04-08
Health Canada
11 findingsStability and storage · Deviation, CAPA, and investigation · Other quality system · Material and supplier control · Equipment and facility · Contamination control · Quality unit oversight · Aseptic processing and sterility assurance · Laboratory and QC controls The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The temperature and/or humidity control was inadequate.
2022-03-21
Health Canada
9 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Other quality system The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. 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.
