Mediscope Ltd. — Health Canada Inspection Findings

The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. Documents were not available on the premises.

The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate.

The written procedures for recalls were inadequate. The computerized system used to manage product inventory and distribution records to support recalls was not validated. The written agreement outlining the respective responsibilities of the importer, distributor, and/or wholesaler for recalls was inadequate.