Jubilant Draximage Inc. dba Jubilant Radiopharma — Health Canada Inspection Findings

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

The receipt, preparation, and/or handling of reagents and culture media was inadequate.

Evaluation of production processes, equipment, and/or materials was inadequate. The master formulas to control the manufacturing process were inadequate.

The investigation, handling, and/or reporting of test results that were out-of-specification 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 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 annual product quality review procedure was inadequate.

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

The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The electronic system was not validated for its intended use.