FDA 483 - Mark Savant, M.D. - April 17, 2024

An FDA inspection of San Francisco Research Institute identified significant deficiencies in the conduct and supervision of an investigation by Dr. Mark J. Savant. Observations included failures to adhere to the investigational plan, improper subject enrollment, inadequate investigational product storage, and lack of personal oversight. Additionally, the firm failed to obtain proper informed consent and did not retain all required investigational records.