Zdrowie i gospodarka · 09/05/2012
Jerome Lentini; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA) is denying Jerome Lentini's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Lentini 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 Lentini was convicted of a felony under Federal law for conduct relating to the development or approval of a drug product or otherwise relating to the regulation of a drug product under the FD&C Act. Lentini has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.