Valhalla Packaging and Distribution Ltd — Health Canada Inspection Findings

The premises were not laid out and/or designed to ensure that production areas were adequately isolated and segregated. The control of quarantine areas was inadequate. The temperature and/or humidity control was inadequate.

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

The master production documents were inadequate.

There was no evidence of a functioning and/or independent quality control department. Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.

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

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.