483
Roger S. Keresztes, M.D.Roger S. Keresztes, M.D. – FDA 483, Dec 12, 2024
Record Details
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.
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