British Columbia Centre for Disease Control and Prevention Society Branch — Health Canada Inspection Findings

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler 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.