{"abstract":"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.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2025/03/13/2025-04031.html","cfr_references":[],"citation":"90 FR 11988","comment_url":"http://www.regulations.gov/commenton/FDA-2024-N-4887-0002","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is applicable March 13, 2025.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-4887"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-03-13","updated_at":"2025-03-13T09:58:18.977-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-4887-0002","allow_late_comments":true,"id":"FDA-2024-N-4887-0002","comment_end_date":null,"regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2024-N-4887","title":"NOOH Proposal to Debar John W. Kosolcharoen"}],"document_number":"2025-04031","effective_on":null,"end_page":11990,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/03/13/2025-04031.xml","html_url":"https://www.federalregister.gov/documents/2025/03/13/2025-04031/john-warrington-kosolcharoen-final-debarment-order","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-04031?publication_date=2025-03-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-03-13/2025-04031/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1092,"last_updated":"2026-04-06 16:15:13 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-03-13/pdf/2025-04031.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-04031.pdf?1741783517","publication_date":"2025-03-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/03/13/2025-04031.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2024-N-4887","supporting_documents_count":0,"docket_id":"FDA-2024-N-4887","document_id":"FDA-2024-N-4887-0002","regulation_id_number":null,"title":"NOOH Proposal to Debar John W. Kosolcharoen","checked_regulationsdotgov_at":"2025-07-13T04:05:44Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2024-N-4887-0002","significant":null,"signing_date":null,"start_page":11988,"subtype":null,"title":"John Warrington Kosolcharoen: Final Debarment Order","toc_doc":"John Warrington Kosolcharoen","toc_subject":"Final Debarment Order","topics":[],"type":"Notice","volume":90}