BWXT Medical Ltd. — Health Canada Inspection Findings

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 temperature and/or humidity control was inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The company's monitoring of water testing was inadequate. The operation of the water purification equipment was inadequate for ensuring a reliable source of water.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The sampling plan for raw materials was inadequate. Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

The receipt, preparation, and/or handling of reagents and culture media 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 sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The annual product quality review procedure was inadequate.

For sterile drugs, the stability program did not include a confirmation of sterility at the initial testing and at the end of the drug's shelf life. The ongoing stability program for a drug was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate.