Innomar Strategies Inc — Health Canada Inspection Findings

The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate. The evidence required to demonstrate compliance with finished product specifications was inadequate.

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

The implementation of a self-inspection program was inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

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

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.