If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is
engaged in manufacturing/processing, packing, or holding of food for human or animal
consumption in the United States, you must register with FDA, unless you are exempt under 21
CFR 1.226 from the requirement to register. If you are an owner, operator, or agent in charge
of a domestic facility, you must register your facility whether or not the food from the facility
enters interstate commerce (21 CFR 1.225(b)). If you are the owner, operator, or agent in
charge of a facility, you may authorize an individual to register your facility on your behalf (see
21 CFR 1.225(c) and 1.230(a)). A foreign facility’s U.S. agent may, but is not required to,
register the facility (21 CFR 1.230).
