Areas cited
Other quality systemEquipment and facilityLaboratory and QC controlsMaterial and supplier controlDeviation, CAPA, and investigationComputer system validationTraining and personnelRegulatory reporting and change controlQuality unit oversightComplaint and recall handlingCleaning validationStability and storage
Published inspection documents
2026-06-09
Health Canada
13 findingsComputer system validation · Equipment and facility · Deviation, CAPA, and investigation · Other quality system · Quality unit oversight · Regulatory reporting and change control · Material and supplier control · Laboratory and QC controls The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
2024-09-09
Health Canada
13 findingsMaterial and supplier control · Training and personnel · Laboratory and QC controls · Equipment and facility · Other quality system · Computer system validation · Deviation, CAPA, and investigation The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
2022-06-28
Health Canada
3 findingsOther quality system · Material and supplier control Lots or batches of finished product did not comply with the specifications and were made available for further fabrication or sale.
2021-03-29
Health Canada
22 findingsComplaint and recall handling · Quality unit oversight · Other quality system · Equipment and facility · Laboratory and QC controls · Training and personnel · Stability and storage · Deviation, CAPA, and investigation · Cleaning validation · Computer system validation · Regulatory reporting and change control The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products 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.
