FDA 483 - Scott T. Guenthner M.D. - September 26, 2019

The FDA inspected Scott T. Guenthner, M.D., Principal Investigator in Plainfield, IN, and issued a Form 483 with two observations. The inspection revealed that the investigation was not conducted in accordance with the investigational plan, specifically regarding the timing of subject assessments. Additionally, the firm failed to maintain accurate case histories, with discrepancies found between source documents and the Subject Drug Accountability Log for investigational product administration.