1Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were 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
2Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Material and supplier control
The protection of products and/or materials from contamination was inadequate.
5Other quality system
The airborne particle monitoring system was inadequate.
6Other quality system
The recorded information or details were inadequate.
7Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-08. 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.
