Cosmaceutical Research Lab Inc. — Health Canada Inspection Findings

The availability, implementation, and/or quality of the written sanitation program was inadequate. The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

The master formulas to control the manufacturing process were inadequate. The master production documents were inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The design, construction, and/or location of the equipment did not allow adequate cleaning, sanitizing, and/or inspection of the equipment. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The written hygiene program did not clearly define clothing requirements and/or hygiene procedures for personnel and/or visitors.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.

The creation, maintenance, processing, and/or review of laboratory data was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The maintenance of records was inadequate.

The specifications for any packaging materials were incomplete or inadequate. The quality control department's release of packaging materials for use in packaging or labelling was inadequate.

The sampling plan for raw materials was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The maintenance of personnel records was inadequate.