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

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.