Charles Tennant & Co (Canada) Ltd. — Health Canada Inspection Findings

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 to release finished products was inadequate.

For imported products, the stability studies from foreign sites were not compliant with Canadian good manufacturing practices and/or Canadian marketing authorization.

The ongoing stability program for a drug 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 handling of standard operating procedures for good manufacturing practices was inadequate.

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

The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

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