Biomed Pharma — Health Canada Inspection Findings

The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.

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 evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.

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

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The evidence required to demonstrate compliance with finished product specifications was inadequate.

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

The written procedures for recalls were inadequate.

The electronic system was not validated for its intended use. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The maintenance of distribution records for drugs was inadequate.

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

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. Documents were not available on the premises.