Azelis Canada Inc — Health Canada Inspection Findings

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 temperature and/or humidity control was inadequate.

Complete testing was not performed according to the requirements. The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate. Tests were not performed according to approved specifications.

The ongoing stability program for a drug was inadequate.

The implementation of a self-inspection program was inadequate.

The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.

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

The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. The recorded information or details were inadequate.

The controls put in place for electronic signatures were inadequate.

The training of personnel before new or revised standard operating procedures were implemented was inadequate.

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

The written procedures for recalls were inadequate.

The quality control department's handling of complaints and/or information received about drug quality was inadequate.

The annual product quality review procedure was inadequate.

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