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).
The qualification and/or verification of utilities and/or support systems was inadequate.
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
The electronic system was not validated for its intended use.
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
Investigations into deviations, reports, and/or follow-up actions were inadequate.
The written specifications were inadequate.
Extracted automatically from the document of the Health Canada inspection on 2021-05-10. 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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