# FDA 483 - Elyse S. Rafal, M.D. - November 24, 2025

Source: https://www.globalkeysolutions.net/records/483/elyse-s-rafal-md/6d0f532b-adaa-47bc-8802-9a4bbfa0a245

> FDA 483 for Elyse S. Rafal, M.D. on November 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elyse S. Rafal, M.D.
- Inspection Date: 2025-11-24
- Product Type: drugs
- Office Name: New York District Office
- Summary: This FDA Form 483 was issued to Elyse S. Rafal, M.D., a clinical investigator in Stony Brook, NY, following an inspection. The primary finding was that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, two subjects in a double-blind study signed an incorrect informed consent form but were still enrolled, randomized, and dosed.

## Related Officers

- [Roberto A. Dookhan](https://www.globalkeysolutions.net/people/roberto-a-dookhan/01c2225f-a885-4421-9967-da323ce55cd8)

Company: https://www.globalkeysolutions.net/companies/elyse-s-rafal-md/aa8514f3-88d5-4eaf-a609-5b928a2a542c

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