Kohl & Frisch Limited — Health Canada Inspection Findings

The quality control department did not undertake all of the required activities. 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 implementation of a self-inspection program was inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.

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

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

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

The ongoing training of personnel was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.

The temperature and/or humidity control was inadequate.