After a foreign facility submits a registration, FDA will verify that the person or entity identified as the U.S. Agent has agreed to serve.
FDA will not confirm any registration or provide the foreign facility with a registration number until the U.S. Agent’s confirmation within 30 days.
The information to be collected from the U.S. Agent includes name, full address, phone number, email address, and emergency contact phone number.
Beginning January 4, 2020, registrations, registration renewals, updates, or cancellations must be submitted to the FDA electronically, unless FDA has granted a waiver.
Our U.S. Agent Service is always included with the following, and therefore free:
- Food Facility Registration
- Dietary Supplements Facility Registration
- Food Canning Establishment (FCE) Registration
- OTC Drug Establishment Registration
- Prescription Drug Establishment Registration
- Medical Devices Establishment Registration
- Cosmetics Establishment Registration
When the confirmation notification of a foreign facility registration is sent to the facility, a confirmation will also be sent to the U.S. Agent to ensure that the U.S. Agent is aware of the connection with each foreign facility registration.
Additionally, because U.S. Agents would have direct access to a list of facilities identifying them as U.S. Agent, the identification system will limit the number of unauthorized and/or fraudulent U.S. Agent listings. U.S. Agents can also electronically notify FDA that they decline to serve as or no longer serve as the U.S. Agent for a foreign facility.
If the U.S. Agent wishes to no longer serve the already-registered foreign facility, the foreign facility will have 60 calendar days to update the facility’s registration with a new U.S. Agent.
ITB HOLDINGS LLC has been U.S. Agent for companies based in China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Russia | Brazil | Spain | Netherlands | Belgium | Sweden | Denmark | Australia | Ireland | Poland | Czech Republic | United States, and many other countries, since 2009.
We make it easy and affordable for all. Check our services and enjoy lowest fees, here.