PLZ Corp. — Health Canada Inspection Findings

Evaluation of production processes, equipment, and/or materials was inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification 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 handling of standard operating procedures for good manufacturing practices was inadequate.

The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.

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