FDA 483 - Michael T. Somenek, M.D. - October 10, 2025

An FDA inspection of Michael T. Somenek, M.D., a clinical investigator in Washington, DC, revealed a significant deviation from clinical study protocols. The firm failed to conduct an investigation according to the signed agreement and investigational plan, specifically by allowing an unqualified Study Coordinator to perform follow-up medical assessments on study subjects instead of the Investigator. This indicates a serious lapse in adherence to study protocols and proper oversight of clinical trial conduct.