1Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The electronic system was not validated for its intended use.
Inspection Record
Q-Pharm Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The quality control department's release of packaging materials for use in packaging or labelling was inadequate.
3Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination. The doors, windows, walls, ceilings, and/or floors were inadequate.
4Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The retention time for records was inadequate.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
7Stability and storage
The temperature and/or humidity control was inadequate.
8Other 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 2026-06-15. 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.
