1Equipment and facility
The maintenance of records 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
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Laboratory and QC controls
The handling of standard operating procedures for good manufacturing practices was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.
4Computer system validation
The preventative maintenance and repair of the equipment was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-05. 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.
