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Zdrowie i gospodarka · 3/15/2022

Nayade Varona: Final Debarment Order

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Nayade Varona from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Varona was convicted of a felony under Federal law for conduct related to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Ms. Varona was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of December 22, 2021 (30 days after receipt of the notice), Ms. Varona had not responded. Ms. Varona's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →