British Columbia Centre for Disease Control and Prevention Society Branch — Health Canada Inspection Findings

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

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

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

The system for reviewing, revising, and approving standard operating procedures was inadequate. The quality control department or the designated alternate did not sign and/or date quality control decisions.

The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls 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 before new or revised standard operating procedures were implemented was inadequate.

The written procedures for recalls were inadequate.