Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. The confirmatory tests conducted on samples before or after they were received in Canada 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 assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
The written procedures for recalls were inadequate.
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2022-09-13. 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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