We Supply Inc. — Health Canada Inspection Findings

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training, experience, and/or reporting structure of the individual responsible for packaging operations 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 controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The temperature and/or humidity control was inadequate.

Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.

The maintenance of the premises was inadequate.

The computerized system used to manage product inventory and distribution records to support recalls was not validated.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.