Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The design, construction, and/or location of the equipment did not allow adequate cleaning, sanitizing, and/or inspection of the equipment. The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug. The usage logs for the equipment used for significant processing and/or testing operations were 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 sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Extracted automatically from the document of the Health Canada inspection on 2025-02-03. 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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