FDA 483 - Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma - March 13, 2024

This FDA Form 483 documents observations from an inspection of Jubilant Draximage Radiopharmacies Inc. dba Jubilant Radiopharma, a nuclear pharmacy located at 4205 Vineland Rd Ste L13, Orlando, FL 32811-6601. The inspection was conducted from March 5, 2024, to March 13, 2024, and the report was issued to Dr. Larry E. Jones Jr., Pharmacy Manager.

The inspection revealed six observations:

1. **Aseptic Processing Outside ISO 5 Area:** On March 6, 2024, during Gozetotide (Illucix) Cold Kit Lot# K-20240306-069 production, the Pharmacy Manager performed aseptic connections (connecting sterile (b)(4) to the Gallium Generator and sterile (b)(4) to the Gallium Generator) in the ISO-7 aseptic processing area, not the required ISO 5 area. 2. **Blocked "First Air" in ISO 5 Area:** On March 6, 2024, during the same Gozetotide production, the Pharmacy Manager was observed blocking first pass air in the ISO-5 (b)(4) flow hood. 3. **Use of Non-Sterile Disinfecting Agents and Cleaning Pads:** The firm uses