Areas cited
Other quality systemDeviation, CAPA, and investigationComputer system validationComplaint and recall handlingEquipment and facilityStability and storageTraining and personnelRegulatory reporting and change control
Published inspection documents
2025-08-06
Health Canada
6 findingsEquipment and facility · Other quality system · Computer system validation · Complaint and recall handling · Deviation, CAPA, and investigation Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
2024-05-16
Health Canada
9 findingsDeviation, CAPA, and investigation · Other quality system · Training and personnel · Stability and storage · Computer system validation · Regulatory reporting and change control · Complaint and recall handling The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
2021-04-14
Health Canada
6 findingsComputer system validation · Equipment and facility · Stability and storage · Other quality system · Deviation, CAPA, and investigation The electronic system was not validated for its intended use. The calibration, inspection, and/or qualification of the equipment, including computerized systems, 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.
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