Promotional Print & Packaging Inc. — Health Canada Inspection Findings

The handling of standard operating procedures for good manufacturing practices was inadequate. The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.

The implementation and/or maintenance of the quality management system was inadequate. The education, experience, and/or oversight of the individual in charge of the quality control department was inadequate. The training, experience, and/or reporting structure of the individual responsible for packaging operations was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records 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. The master production documents were inadequate. Line clearance was not performed before starting new processing operations.

The written procedures for recalls were inadequate.

The electronic system was not validated for its intended use.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The quality control department's approval was inadequate for raw materials, packaging materials, labelling, finished products, and/or products being reprocessed.

The temperature and/or humidity control was inadequate.