United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2025_register executive 2025-03-13 article Notices D09002ee1d0a392ab D09002ee1d0a39309 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 90 FR 11988 https://www.govinfo.gov/app/details/FR-2025-03-13/2025-04031 2025-04031 fr13mr25-55 4164-01-P Docket No. FDA-2024-N-4887 https://www.govinfo.gov/app/details/FR-2025-03-13/2025-04031 https://www.govinfo.gov/content/pkg/FR-2025-03-13/html/2025-04031.htm https://www.govinfo.gov/content/pkg/FR-2025-03-13/pdf/2025-04031.pdf 3 p. 11988 11990 90 FR 11988 John Warrington Kosolcharoen: Final Debarment Order; Federal Register Vol. 90, Issue NOTICE 2025-04031 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2024-N-4887 4164-01-P 2025-04031 Notice.

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.

This order is applicable March 13, 2025. Jaime Espinosa, Division of Field Enforcement, Office of Field Regulatory Operations, Office of Inspections and Investigations, Food and Drug Administration, at 240- 402-8743, or debarments@fda.hhs.gov. Final Debarment Order John Warrington Kosolcharoen, debarments@fda.hhs.gov https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 90, no. 48 Office of the Federal Register, National Archives and Records Administration 2025-03-13 continuing daily deposited born digital 222 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2025-03-13 P0b002ee1d0a35d3b 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13mr25 https://www.govinfo.gov/app/details/FR-2025-03-13 https://www.govinfo.gov/content/pkg/FR-2025-03-13/pdf/FR-2025-03-13.pdf https://www.govinfo.gov/content/pkg/FR-2025-03-13/xml/FR-2025-03-13.xml fdlp 11891 12103 DGPO 2025-03-13 2025-03-13 FR-2025-03-13 machine generated eng FR FR-2025-03-13 90 48