FDA Terminating Winne’s Debarment

Federal Register notice: FDA is issuing an order granting special termination of the debarment of David Winne, effective 8/28/2024. In August, Winne was permanently debarred from providing services related to an approved or pending drug product application. The debarment was based on Winne’s felony convictions as a technical director with AMA Laboratories, a consumer product testing company. According to the debarment notice, FDA found that from 1987 to 2017, Winne and other AMA personnel defrauded customers by testing products on fewer panelists than were agreed upon. In its order to terminate Winne’s debarment after one year, FDA says it based its decision on a finding that he provided substantial assistance in a matter under FDA’s jurisdiction, and that terminating the debarment serves the interest of justice and does not threaten the integrity of the drug approval process. To view the notice, click here.