1Aseptic processing and sterility assurance
The company's monitoring and documentation of heat sterilization cycles 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.
3Other quality system
The recorded information or details were inadequate.
4Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
5Equipment and facility
Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
6Material and supplier control
Printed packaging materials were not stored in an area with restricted access.
7Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
8Aseptic processing and sterility assurance
The company did not continually monitor the differences in air pressure between aseptic areas and adjacent areas.
9Stability and storage
The ongoing stability program for a drug was inadequate.
10Other quality system
The airborne particle monitoring system was inadequate.
11Other quality system
The assessment to release finished products was inadequate.
12Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-04-14. 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.
