Miguel Angel Montalvo Villa: Final Debarment Order
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Miguel Angel Montalvo Villa 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 Mr. Montalvo Villa was convicted of multiple felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mr. Montalvo Villa was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 19, 2024 (30 days after receipt of the notice), Mr. Montalvo Villa has not responded. Mr. Montalvo Villa's failure to respond and request a hearing constitutes a waiver of Mr. Montalvo Villa's right to a hearing concerning this matter.
Abstract as published in the Federal Register.
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