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FDA registration is required for all facilities that manufacture, process, pack, or store food, beverages, or dietary supplements that may be consumed in the United States by humans or animals. Companies located outside the United States must designate a U.S. Agent for FDA communications.
The appointment of US Agents is a mandatory requirement for foreign companies who wish to market their food products in USA. Here at U.S FDA Services, we have established experience of providing US Agent services. The FDA communicates with foreign companies through their US Agent, and our experience means that we understand the importance of such confidential information
We provide US agent services at competitive fees.
If you have multiple facilities, we can offer you a discounted fee. Please contact us for more information
FDA-registered food facilities are required to register with FDA and renew their registration every other year on even-numbered years.
All drug establishments and food facilities are now required to submit Unique Facility Identifiers (UFIs) as part of their initial FDA registration as well as their registration renewal. Currently, the only UFI recognized by FDA is the DUNS number.
NEW IN 2022: All registered food facilities must include their DUNS number in their registration renewal for the October-December 2022 renewal period.
All registered food facilities located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments and assist in organizing food facility inspections.
All registered food facilities located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments and assist in organizing food facility inspections.
FDA requires the filing of Prior Notice for all food, beverage, and dietary supplements shipments entering the United States. Prior Notice submissions must contain certain pieces of information, including a valid FDA registration number.
U.S FDA Services has provided US agent and regulatory services for the last 10 years, supporting clients across the globe. We have expertise in handling regulatory matters and communication with the FDA, an essential element of successful consultancy services.