Microbios Analytique Inc. — Health Canada Inspection Findings

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

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate.

The maintenance of detailed plans or specifications was inadequate for each building where drugs are fabricated, packaged, labelled, and/or tested.

The preventative maintenance and repair of the equipment 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 system for reviewing, revising, and approving standard operating procedures was inadequate.

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