Groupe AFFI Logistique - Division Saint-Hubert — Health Canada Inspection Findings

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 handling of standard operating procedures for good manufacturing practices was inadequate. The system for reviewing, revising, and approving standard operating procedures was inadequate.

The temperature and/or humidity control was inadequate.

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

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

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

The quality control department did not undertake all of the required activities.