Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
The temperature and/or humidity control was inadequate.
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
The implementation of a self-inspection program was inadequate. The written self-inspection procedure was inadequate.
The premises were not laid out and/or designed for an optimal flow of personnel and/or materials to prevent cross-contamination and/or mix-ups between products.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
The maintenance of records was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2023-03-21. 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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