Pharm-Medics Inc. — Health Canada Inspection Findings

Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The quality control department did not undertake all of the required activities.

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.

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

The control of quarantine areas was inadequate.