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

An FDA inspection of Scott A. Fretzin, M.D., a clinical investigator in Indianapolis, revealed a failure to conduct a clinical study in accordance with good clinical practices. The inspection found issues with enrolling subjects who did not meet protocol-required eligibility criteria and not adhering to the investigational plan regarding primary source documents and prohibited medication instructions. These findings indicate significant deviations in the conduct of the clinical trial.