Diversey Canada Inc. — Health Canada Inspection Findings

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The operation of the water purification equipment was inadequate for ensuring a reliable source of water.

Investigations into deviations, reports, and/or follow-up actions were inadequate. The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products. The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.

The annual product quality review procedure was inadequate.

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The master production documents were inadequate. Yields and/or the reconciled quantities were not checked at appropriate stages. Investigations into deviations, reports, and/or follow-up actions were inadequate.

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

The implementation of a self-inspection program was inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification 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 of personnel before new or revised standard operating procedures were implemented was inadequate.

The assessment to release finished products was inadequate.