Angela D. Ritter, M.D. – FDA 483, Aug 17, 2023

An FDA inspection of Angela D. Ritter, M.D. in Gainesville, GA, a sponsor-investigator, revealed significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan, did not obtain proper IRB approval for protocol changes and subsequent emergency uses of the investigational product, and lacked adequate informed consent. Additionally, the firm failed to submit required annual reports to the FDA.