FDA 483 - Fayz A. Hudefi, M.D. - April 21, 2023

An FDA inspection of Fayz A. Hudefi, M.D. in Bentonville, AR, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to investigational plans, exhibiting issues with subject identification, data integrity, and protocol compliance within the residential unit. Additionally, the clinical investigator did not report non-serious adverse events to the sponsor in a timely manner.