Zdrowie i gospodarka · 19.03.2020
Stephen Kalinoski: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Stephen Kalinoski 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 Mr. Kalinoski was convicted of a felony for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kalinoski was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Kalinoski failed to respond. Mr. Kalinoski's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.