FDA EIR - Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma - March 13, 2024

An unannounced, comprehensive FDA inspection of Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma in Orlando, FL, occurred from March 5-13, 2024. This inspection, the firm's first, focused on sterile compounding of radiopharmaceutical products, including Gallium (68) Gozetotide and White Blood Cell products. The regulatory framework for this inspection included guidance on Insanitary Conditions at Compounding Facilities and Compounding and Repackaging of Radiopharmaceuticals. The inspection resulted in a six-item Form FDA 483, detailing significant observations. Key issues included personnel performing aseptic processing outside an ISO 5 area and blocking critical airflow within the ISO 5 zone. The firm was also cited for using non-sterile disinfectants and cleaning pads in the critical ISO 5 area. Further observations involved inadequately performed dynamic smoke studies, failure to conduct media fills that accurately simulate worst-case aseptic production, and insufficient routine environmental monitoring in classified areas. Management, including Pharmacy Manager Dr. Larry E. Jones, Jr., received the observations. The company committed to providing an official response within 15 business days, indicating they had already begun implementing changes. Jubilant Radiopharma outlined a corrective action plan to assess gaps against relevant guidelines (USP <825>, FLBOP, Insanitary Conditions), implement immediate corrective and preventive actions locally, and integrate these findings into their broader quality program and standard operating procedures across their pharmacy network.