FDA 483 - Wayne Farnsworth, MD - June 27, 2023

An FDA inspection of Wayne J. Farnsworth, M.D., Clinical Investigator in Rockville, MD, revealed significant deficiencies in conducting a clinical investigation. The firm failed to adhere to the signed statement of investigator and investigational plan, specifically regarding numerous missed protocol events and missing source documentation. This indicates a serious lack of adherence to clinical trial protocols and record-keeping requirements.