The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Canadian Custom Packaging Company — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The ongoing stability program for a drug was inadequate.
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The maintenance of records was inadequate.
The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.
Evaluation of production processes, equipment, and/or materials was inadequate.
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 2026-08-12. 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.
