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

Source: https://www.keypedia.com/records/483/roger-s-keresztes-md/fbae016b-f573-432d-b57d-2db8a50633fd

> FDA 483 for Roger S. Keresztes, M.D. on December 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roger S. Keresztes, M.D.
- Inspection Date: 2024-12-12
- Product Type: drugs
- Office Name: New York District Office
- Summary: 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.

## Related Documents

- [483 - 2019-09-27](https://www.keypedia.com/records/483/roger-s-keresztes-md/3b80e05b-f5da-4262-8b5c-ed5352368389)

## Related Officers

- [Bernardica T. Sculac Stern](https://www.keypedia.com/people/bernardica-t-sculac-stern/44ff2730-4410-4b72-819c-4b90e8904f33)

Company: https://www.keypedia.com/companies/roger-s-keresztes-md/54869ce0-0f14-4703-99c0-6ce30ef2ac9e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d