FDA 483 - Scott A. Fretzin, M.D. - May 01, 2025

An FDA inspection of Scott A. Fretzin, M.D. in Indianapolis, IN, identified a failure to conduct a clinical study in accordance with good clinical practices. The inspection revealed issues with enrolling subjects who did not meet protocol-required eligibility criteria and a lack of adherence to the investigational plan, including maintaining primary source documents for washout periods. These findings indicate significant deficiencies in the oversight and execution of the clinical trial.