FDA will not complete a registration or provide a registration number until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment.
Foreign manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, preparation, propagation, compounding, processing or testing of human or veterinary drugs and human biological products, including the manufacturers of APIs, must have a U.S. Agent.
Food Facility, Supplement Facility and Food Canning Establishment registrations require a U.S. Agent, as well.
ITB HOLDINGS LLC is the U.S. Agent of companies in Canada, Mexico, Brazil, Australia, New Zealand, India, Pakistan, South Korea, Japan, China, Russia, Portugal, Greece, Spain, France, Belgium, Netherlands, Switzerland, Sweden, United Kingdom, Ireland, among more than 100 countries.
The U.S. Agent’s responsibility is to be the Foreign Facility’s contact for the FDA, in both emergencies and routine operations.
■ Commercial Agent
■ Customs Broker
■ Initial Importer
■ Importer of Record
■ FSVP Importer
U.S. Agent Service is always included, and therefore free, when one of our services is requested.