Unless exempt, all domestic and foreign facilities or establishments manufacturing, holding, exporting, importing and distributing FDA regulated products, are required to register with the U.S. Food and Drug Administration, and renew related registrations. 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.usfda.info/fsvp/