Accuristix — Health Canada Inspection Findings

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

The annual product quality review procedure was inadequate.

Bulk drugs, in-process drugs, raw materials, or packaging materials were not labelled with all the required information.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The written specifications were inadequate.

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

The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing 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.

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