⚖️Implications of John Kosolcharoen's FDA Debarment Order
John Warrington Kosolcharoen: Final Debarment Order
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The debarment of John Warrington Kosolcharoen under the FD&C Act has significant implications for companies involved in drug product applications. Businesses must ensure compliance to avoid penalties if they engage individuals under debarment, reflecting regulatory responsibility.