Pro-Tam — Health Canada Inspection Findings

The ongoing training of personnel was inadequate.

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The recorded information or details were inadequate. Samples of the printed packaging materials were not attached to the packaging orders. Printed packaging materials were not stored in an area with restricted access. The handling of rejected materials and products was 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 calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

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

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The establishment and/or the maintenance of a data governance plan was inadequate.