1Other quality system
The assessment to release finished products was inadequate.
Inspection Record
Apotex Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
3Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
4Other quality system
The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
5Equipment and facility
The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-11-10. 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.
