The Shandex Sales Group Limited — Health Canada Inspection Findings

The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation 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 annual product quality review procedure was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

There was a lack of or inadequate evidence to demonstrate that all buildings involved in the production, distribution and/or importation of APIs met good manufacturing practices requirements.