Purdue Pharma — Health Canada Inspection Findings

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The ongoing training of personnel was inadequate.

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