We can assist you in registering your food facility with the United States Food & Drug Administration
Owners, operators, or agents in charge of facilities located within or outside the USA that manufacture, process, pack, or hold food for consumption in the United States are required to register the facility with the United States FDA. Facilities that manufacture, process, pack, or hold food are also required to register unless food from that facility undergoes further processing (including packaging) by another non-US facility before the food is exported to the USA.
Examples of FDA-regulated Foods
What Information Is Required?
We can act as your U.S. FDA Agent for your Facility
The U.S. FDA agent acts as a communications link between FDA and the foreign facility. FDA treats representations by the U.S. FDA agent as those of the foreign facility, and will consider information or documents provided to the U.S. FDA agent equivalent to providing the information or documents to the foreign facility. A U.S. FDA agent cannot be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's U.S. FDA agent is not physically present.
Farms; retail food establishments; restaurants; non-profit establishments that prepare
food for, or serve food directly to, consumers; fishing vessels not engaged in processing
and facilities regulated exclusively throughout the entire facility by the U.S. Department
of Agriculture are exempt from registration.
U.S. Congress Approves Food Safety Legislation, expands FDA’s Authority to Regulate Food Imports into the USA