Zdrowie i gospodarka · 4.08.2009
Paul H. Kornak: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Paul H. Kornak 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 Paul H. Kornak was convicted of three felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Kornak failed to request a hearing. Mr. Kornak's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.