Health CanadaInspected 2024-10-306 findingsAseptic processing and sterility assuranceContamination controlRegulatory reporting and change controlDeviation, CAPA, and investigationComputer system validationEquipment and facility
The company's investigations of microbial contamination in critical areas were inadequate. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. Evaluation of production processes, equipment, and/or materials was inadequate. The quality control department did not undertake all of the required activities.
2Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The written sanitation program for clean areas was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-10-30. The source is available at the link above.
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.
Translation and classification are automated and may differ in nuance from the source.
