Areas cited
Other quality systemDeviation, CAPA, and investigationRegulatory reporting and change controlMaterial and supplier controlComputer system validationEquipment and facilityLaboratory and QC controlsQuality unit oversightCleaning validationStability and storage
Published inspection documents
2026-02-09
Health Canada
12 findingsLaboratory and QC controls · Stability and storage · Other quality system · Computer system validation · Material and supplier control · Deviation, CAPA, and investigation · Regulatory reporting and change control The creation, maintenance, processing, and/or review of laboratory data was inadequate.
2024-02-12
Health Canada
12 findingsRegulatory reporting and change control · Equipment and facility · Material and supplier control · Other quality system · Deviation, CAPA, and investigation · Cleaning validation · Quality unit oversight · Computer system validation The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
2023-03-06
Health Canada
5 findingsComputer system validation · Deviation, CAPA, and investigation · Material and supplier control · Equipment and facility · Other quality system The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
2021-03-04
Health Canada
10 findingsRegulatory reporting and change control · Laboratory and QC controls · Other quality system · Deviation, CAPA, and investigation · Quality unit oversight The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
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.
