Can a foreign company register an establishment or facility with the United States Food and Drug Administration (U.S. FDA) without a U.S. Agent? The answer is no. Keep that in mind. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.fda.itbhdg.com/product/fsvp/