1Complaint and recall handling
The written procedures for recalls were inadequate.
Inspection Record
Rusan Pharma Canada 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.
3Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
5Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
6Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
7Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-06-22. 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.
