1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification 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
2Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Stability and storage
The ongoing stability program for a drug was inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Other quality system
The recorded information or details were inadequate.
8Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-14. 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.
