CDMV Inc. — Health Canada Inspection Findings

The written procedures for recalls were 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 number of personnel with the necessary qualifications and/or on-site experience was inadequate.

The system for reviewing, revising, and approving standard operating procedures was inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. The quality control department's handling of complaints and/or information received about drug quality 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 maintenance of records was inadequate.

The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug 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.