Foreign establishments or facilities exporting to the United States must identify an FDA U.S. Agent during the registration process.
Each foreign establishment may designate only one U.S. Agent.
FDA treats representations by the U.S. Agent as those of the foreign facility, and will consider information or documents provided to the U.S. Agent the equivalent of providing the information or documents to the foreign facility.
The FDA U.S. Agent has no responsibility related to adverse events under the Medical Device Reporting regulation.
Foreign companies (facilities or establishments) must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the company and the U.S. Food and Drug Administration (U.S. FDA). The U.S. Agent is authorized to register any facility.
FDA will not confirm a registration, provide a registration number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
The agency will conduct this verification step by sending an email to ITB HOLDINGS LLC. If the FDA does not receive a response to its verification request within 30 calendar days, the registration, registration renewal, update, or cancellation submission will be removed from its database and a new submission will be required.
As U.S. Agent, we register your domestic and or foreign company at no extra cost. Join satisfied clients in over 100 countries including Canada, Mexico, Brazil, Australia, India, South Korea, Japan, China, Russia, Greece, Portugal, Spain, Italy, France, Switzerland, Belgium, Netherlands, Sweden, United Kingdom, Ireland.
Please do not assume that a U.S. Agent is or can be any of the following, as each play a different and separate role that comes with unique responsibilities:
▪ Commercial Agent.
▪ Customs Broker.
▪ Initial Importer.
▪ Importer of Record (IOR).
▪ Foreign Supplier Verification (FSVP) Importer.
The United States Agent is responsible for reviewing, disseminating, routing, and responding to all communications from the FDA including in case of an emergency.
We make the process very easy. Get the better service your company deserves.
When a foreign facility uses a U.S. Agent identification number in accordance with the Voluntary Identification System (VIS), and the name of the facility matches the facility name and address the U.S. Agent has identified, FDA will consider that verification without taking any additional steps to verify the U.S. Agent. Thus, the process of providing a food facility registration number, is facilitated.