FDA 483 - Stanford University School of Medicine Radioactive Drug Research Committee - April 21, 2025

An FDA inspection of Stanford University School of Medicine's Radioactive Drug Research Committee (RDRC) identified significant deficiencies in their oversight of radioactive drug research studies. Observations included failures to ensure radioactive drug quality, sterility, and proper labeling, as well as a lack of documentation for informed consent from human subjects. These issues indicate a serious lapse in regulatory compliance and patient safety protocols for research involving radioactive drugs.