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

Jubilant DraxImage Radiopharmacies Inc. dba Jubilant Radiopharma, a nuclear pharmacy in Orlando, FL, was cited for multiple deficiencies during an FDA inspection. Observations included personnel performing aseptic processing outside of ISO 5 areas, inadequate environmental controls, and insufficient quality assurance practices. These issues collectively indicate a lack of control over conditions critical to maintaining product sterility.