FDA 483 - Jubilant Draximage Radiopharmacies Inc - January 09, 2015

Triad Isotopes Inc., a producer of sterile injectable radiopharmaceutical drug products, underwent an FDA inspection from January 5-9, 2015, revealing significant concerns regarding its manufacturing and quality control practices. The inspection highlighted deficiencies in aseptic processing, including inappropriate personnel clothing. Operators used non-sterile gloves and forearm covers in unclassified areas before sterilizing them and beginning aseptic operations in ISO 5 laminar flow hoods, lacking data to confirm sterility wasn't compromised. Environmental controls were inadequate, with insufficient monitoring data for ISO 5 hoods and a missed testing schedule. The ISO 5 hoods themselves were improperly modified; equipment was mounted below HEPA filters, disturbing unidirectional airflow, and internal covers were removed, creating unsanitary conditions with exposed wiring and lights. Furthermore, the hoods lacked essential magnehelic gauges for daily performance evaluation. Laboratory controls for ensuring drug product quality were also found lacking. Annual media fills, critical for evaluating aseptic technique, used an improperly worded procedure and incubation temperatures below the optimal range, potentially leading to false negative results for microbial growth. Finally, the quality control unit failed to consistently follow its own written procedures, with missing approvals on equipment cleaning logs and corporate procedures not adequately tailored or communicated to site-specific personnel, causing confusion about their responsibilities. Triad Isotopes Inc. is expected to address these observations to ensure compliance with good manufacturing practices for sterile drug production.