McKesson Canada Corporation — Health Canada Inspection Findings

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 calibration, inspection, and/or qualification of the equipment, including computerized systems, 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 traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The quality control department did not undertake all of the required activities.

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.