FDA 483 - Roger S. Keresztes, M.D. - December 12, 2024

An FDA inspection of Roger S. Keresztes, M.D., a clinical investigator in Stony Brook, NY, revealed a significant failure to adhere to an investigational plan. Specifically, the clinical investigator did not discontinue treatment for a subject despite the occurrence of an adverse event of special interest that, per protocol, required treatment cessation. This indicates a serious deviation from study protocol and patient safety guidelines.