FDA 483 - Steven M. Wolf, M.D. - March 05, 2026

An FDA inspection of Steven M. Wolf, M.D. in Hawthorne, NY, identified a significant issue related to clinical trial conduct. The firm, acting as a sponsor-investigator, failed to submit a protocol amendment to the Institutional Review Board and the FDA regarding changes in the maximum dose of an investigational drug. This indicates a lapse in regulatory compliance concerning the oversight and reporting of study modifications.