FDA 483 - UCSF Radiopharmaceutical Facility - July 24, 2025

The FDA inspected UCSF Radiopharmaceutical Facility in San Francisco, CA, a PET drug manufacturer, and found significant deficiencies. Observations included failures in sterility testing, inadequate production and process controls for sterile PET drugs, and non-adherence to quality assurance procedures. These issues raise concerns about the quality and purity of released sterile PET drug products.