AX Pharmaceutical Corp — Health Canada Inspection Findings

The protection of products and/or materials from contamination was inadequate. The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate. The recorded information or details were inadequate.

The ongoing stability program for a drug was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.

The temperature and/or humidity control was inadequate.

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

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