Canadian Hospital Specialties Ltd — Health Canada Inspection Findings

The training of personnel before new or revised standard operating procedures were implemented was inadequate.

The ongoing stability program for a drug was inadequate.

The annual product quality review procedure was inadequate.

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

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.

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 confirmatory tests conducted on samples before or after they were received in Canada were inadequate.

The assessment to release finished products was inadequate. The importer and/or the distributor's compliance with the current master production documents and/or the marketing authorization was inadequate.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

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 temperature and/or humidity control was inadequate.