Medicap Laboratories — Health Canada Inspection Findings

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

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

The qualification and/or verification of utilities and/or support systems was inadequate.

The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The creation, maintenance, processing, and/or review of laboratory data was inadequate.

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

The temperature and/or humidity control was inadequate.

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

The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.