Ivette Maria Portela Martinez: 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 Ivette Maria Portela Martinez 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. Portela Martinez was convicted of two felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Ms. Portela Martinez was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 14, 2024 (30 days after receipt of the notice), Ms. Portela Martinez has not responded. Ms. Portela Martinez's failure to respond and request a hearing constitutes a waiver of Ms. Portela Martinez's right to a hearing concerning this matter.
Abstract as published in the Federal Register.
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