Fresenius Kabi Canada Ltd. — Health Canada Inspection Findings

The written protocol and/or the assessment of the test method transfer was inadequate.

The annual product quality review procedure was inadequate.

There was a lack of or inadequate evidence to demonstrate that all buildings involved in the production, distribution and/or importation of APIs met good manufacturing practices requirements.

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

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 investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.