Aurium Pharma Inc. — Health Canada Inspection Findings

Complete testing was not performed according to the requirements.

The quality control department's handling of complaints and/or information received about drug quality was inadequate.

The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.

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

The ongoing stability program for a drug was inadequate.

Validation studies were not conducted in keeping with the predefined protocols. The master production documents were inadequate.

The assessment to release finished products was inadequate.

There was a lack of or inadequate evidence to demonstrate that all buildings involved in the production, distribution and/or importation of APIs met good manufacturing practices requirements. Active Pharmaceutical Ingredients were manufactured and tested from companies for which GMP compliance information was not available.

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

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.