Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
Investigations into deviations, reports, and/or follow-up actions were inadequate.
The ongoing training of personnel was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
The written specifications were inadequate.
The investigation, handling, and/or reporting of test results that were out-of-specification 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 availability or the content of the authentic certificate of analysis was inadequate.
"The maintenance of records was inadequate.
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
The maintenance of records was inadequate.
Extracted automatically from the document of the Health Canada inspection on 2025-09-02. 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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