1Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
1000098888 Ontario Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
4Stability and storage
The temperature and/or humidity control was inadequate. The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
5Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-22. 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.
