FDA 483 - James Krainson, M.D. - September 22, 2021

James Krainson, M.D., a clinical investigator in Miami, FL, was inspected by the FDA, revealing significant deficiencies in the conduct of a clinical investigation. The primary issue identified was the failure to adhere to the investigational plan and source document requirements, specifically concerning the timely and accurate recording of physical exam data. Data entry into the electronic system for numerous subjects occurred significantly after the actual activity, sometimes days post-dose, indicating a serious lapse in data integrity and record-keeping practices.