UniLab Analytical Services Inc. — Health Canada Inspection Findings

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate. The electronic system was not validated for its intended use.

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 in good manufacturing practices and/or the maintenance of records was inadequate.

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

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

The design, equipment, and/or maintenance of the testing laboratory was inadequate.

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