FDA 483 - David V. Daniels, MD - September 30, 2025

An FDA inspection of David V. Daniels, MD in San Francisco, CA, a clinical investigator, revealed a significant issue with the conduct of an investigation. Specifically, the firm failed to report a subject death within the protocol-defined timeframe, indicating a lack of adherence to the investigational plan and applicable FDA regulations. This suggests a serious lapse in clinical trial oversight and reporting procedures.