1Other quality system
The assessment to release finished products was inadequate.
Inspection Record
Pro Doc Limitée — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The master production documents were inadequate.
3Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
4Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Other quality system
The electronic system was not validated for its intended use. The controls put in place for electronic signatures were inadequate.
7Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2025-08-11. 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.
