Dentsply Canada Limited — Health Canada Inspection Findings

Investigations into deviations, reports, and/or follow-up actions were inadequate. The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.

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

The ongoing stability program for a 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.

The temperature and/or humidity control 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 recorded information or details were inadequate.

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

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).