Areas cited
Aseptic processing and sterility assuranceEquipment and facilityRegulatory reporting and change controlStability and storageDeviation, CAPA, and investigationComputer system validationTraining and personnelOther quality systemCleaning validationLaboratory and QC controlsContamination controlMaterial and supplier control
Published inspection documents
2025-11-24
Health Canada
11 findingsDeviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility · Regulatory reporting and change control · Contamination control · Stability and storage · Computer system validation · Material and supplier control · Aseptic processing and sterility assurance Investigations into deviations, reports, and/or follow-up actions were inadequate.
2024-03-25
Health Canada
3 findingsAseptic processing and sterility assurance · Equipment and facility · Computer system validation The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The process was inadequate for the environmental classification of aseptic or clean areas.
2021-12-06
Health Canada
12 findingsOther quality system · Regulatory reporting and change control · Training and personnel · Deviation, CAPA, and investigation · Cleaning validation · Aseptic processing and sterility assurance · Equipment and facility · Stability and storage The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
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.
