FDA 483 - Ralph A. DeFronzo - December 06, 2024

Ralph A. DeFronzo, M.D., Clinical Investigator, in San Antonio, TX, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures to ensure subjects met eligibility criteria, obtain proper informed consent, and adhere to IRB-approved protocols and screening procedures. These issues indicate a serious lack of adherence to clinical trial regulations and ethical standards.