The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Mayya Tatsene 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. Tatsene was convicted of a felony under Federal law for conduct that relates to the regulation of any drug product under the FD&C Act. Ms. Tatsene 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 July 8, 2023 (more than 30 days after receipt of the notice, as prescribed by regulation), Ms. Tatsene has not responded to the notice. Ms. Tatsene's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.
Abstract as published in the Federal Register.
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