The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Exzell Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
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 maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The written specifications were inadequate.
There was a lack of or inadequate evidence to demonstrate that all buildings involved in the production, distribution and/or importation of APIs met good manufacturing practices requirements.
The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-04-23. 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.
