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

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The training of personnel before new or revised standard operating procedures were implemented was inadequate.

The assessment to release finished products 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 availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate. The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.

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

The quality control department's selection of a laboratory for testing and/or examination was inadequate.

The quality control department did not undertake all of the required activities.