1Other quality system
The handling of standard operating procedures for good manufacturing practices 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
2Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
3Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The operation of the water purification equipment was inadequate for ensuring a reliable source of water.
4Documentation and records
Investigations into deviations, reports, and/or follow-up actions were inadequate. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.
5Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2026-04-13. 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.
