Le Groupe Jean Coutu (PJC) Inc. — Health Canada Inspection Findings

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The electronic system was not validated for its intended use. The controls put in place for electronic signatures were 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 assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.

The implementation of a self-inspection program 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. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.