Nutrimmune Technologies Incorporated — Health Canada Inspection Findings

The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures. The system for reviewing, revising, and approving standard operating procedures was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate.

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

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The ongoing stability program for a drug was inadequate.

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

The implementation of a self-inspection program was inadequate.

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