1Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
Inspection Record
Alberta Health Services — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
3Aseptic processing and sterility assurance
The company did not justify the hold time for sterilized components, containers, or equipment.
4Other quality system
The recorded information or details were inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate. The maintenance of records was inadequate.
7Other quality system
The company's monitoring of water testing was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-01-20. 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.
