FDA 483 - John F. Foley, MD - April 21, 2023

An FDA inspection of John F. Foley, MD, a clinical investigator in Salt Lake City, UT, revealed a significant issue regarding the conduct of an investigation. The firm failed to adhere to the investigational plan, specifically concerning inadequate oversight of study personnel and improper data handling. This resulted in missing original source documents and unauthorized changes to medical records for a study subject.