FDA 483 - UCSF Radiopharmaceutical Facility - July 24, 2020

UCSF Radiopharmaceutical Facility in San Francisco, a PET Manufacturer, received a Form 483 with seven observations related to significant deficiencies in quality control, manufacturing processes, and laboratory procedures. Key issues include failure to investigate out-of-specification results, inadequate change control, unvalidated analytical methods, and insufficient stability testing programs. These findings indicate a lack of robust systems to ensure the quality, purity, and identity of their PET drug products.