CanXpanse Pharma Ltd. — Health Canada Inspection Findings

The system for reviewing, revising, and approving standard operating procedures was inadequate. The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The ongoing training of personnel was inadequate.

The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate. The implementation of a self-inspection program was inadequate.