FDA 483 - Caitlin C. Meyer, M.D. - December 21, 2022

An FDA inspection of Caitlin C. Meyer, M.D., a clinical investigator in North Miami, FL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures in obtaining proper informed consent, maintaining adequate subject case histories, and adhering to the investigational plan, including timely reporting of a serious adverse event. These issues indicate a lack of control over critical aspects of clinical trial management and subject protection.