FDA 483 - Elena Valor, M.D. - October 10, 2023

An FDA inspection of Elena Valor, M.D., a clinical investigator in Miami, FL, revealed significant deviations from investigational plans across two clinical protocols. The inspection found issues including enrollment of ineligible subjects, the unblinded investigator performing blinded assessments, and incorrect investigational product dispensation. These findings indicate a failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan.