FDA 483 - ISORX CYCLOTRON CENTER - March 20, 2025

An FDA inspection of Isorx Cyclotron Center in Lubbock, TX, a manufacturer of PET drugs, revealed significant deficiencies across multiple areas. The firm failed to establish and follow adequate quality assurance procedures, lacked sufficient production and process controls, and had inadequate facilities for contamination prevention. Additionally, critical records were not readily available, and laboratory data integrity was compromised by the absence of audit trails.