Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The process was inadequate for the environmental classification of aseptic or clean areas. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
The system for reviewing, revising, and approving standard operating procedures was inadequate.
Sterile disinfectants were not used in Grade A and B areas. The written clothing standards for each environmental grade were inadequate.
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
Extracted automatically from the document of the Health Canada inspection on 2025-08-20. 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.
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