John Warrington Kosolcharoen: 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 John Warrington Kosolcharoen from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application (BLA). FDA bases this order on a finding that Mr. Kosolcharoen was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kosolcharoen was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 26, 2024 (30 days after receipt of the notice), Mr. Kosolcharoen has not responded. Mr. Kosolcharoen's failure to respond and request a hearing constitutes a waiver of Mr. Kosolcharoen's right to a hearing concerning this matter.
Abstract as published in the Federal Register.
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