# FDA 483 - Steven M. Wolf, M.D. - March 05, 2026

Source: https://www.keypedia.com/records/483/steven-m-wolf-md/a5be4877-ab6e-4636-bbef-4f93663dad47

> FDA 483 for Steven M. Wolf, M.D. on March 05, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steven M. Wolf, M.D.
- Inspection Date: 2026-03-05
- Product Type: other
- Office Name: New York District Office
- Summary: An FDA inspection of Steven M. Wolf, M.D. in Hawthorne, NY, identified a significant issue related to clinical trial conduct. The firm, acting as a sponsor-investigator, failed to submit a protocol amendment to the Institutional Review Board and the FDA regarding changes in the maximum dose of an investigational drug. This indicates a lapse in regulatory compliance concerning the oversight and reporting of study modifications.

## Related Officers

- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)

Company: https://www.keypedia.com/companies/steven-m-wolf-md/d07116c9-f8e0-46ba-8541-633f39ee6f00

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