Chief Medical Supplies Ltd — Health Canada Inspection Findings

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

The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The validation and/or the documentation of test methods was inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.

The protection of products and/or materials from contamination was inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.

The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.