Inspection Record
View the regulator's official source The source document is always the basis for judgement.
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The electronic system was not validated for its intended use. Documents were not available in one of the official languages.
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 evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
The handling of standard operating procedures for good manufacturing practices was inadequate.
Confirmatory testing was not performed by an alternate laboratory.
Extracted automatically from the document of the Health Canada inspection on 2023-03-13. 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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