483
Roger S. Keresztes, M.D.FDA 483 - Roger S. Keresztes, M.D. - December 12, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · fbae016b-f573-432d-b57d-2db8a50633fd