McMahon Distributeur Pharmaceutique Inc. — Health Canada Inspection Findings

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

The electronic system was not validated for its intended use. The controls put in place for electronic signatures were inadequate.

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

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

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

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

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