Under 21 CFR 1.232(c), the registration for a foreign facility is required to include the “name, full address, phone number, and e-mail address of the foreign facility’s U.S. agent. . . .”. “U.S. agent” is defined in 21 CFR 1.227 as a “person . . . residing or maintaining a place of business in the United States whom a foreign facility designates as its agent” for purposes of registration of food facilities. As used in this definition, what does a facility need to do to “designate” a person as a U.S. agent?

A foreign facility’s U.S. agent must reside or maintain a place of business in the United States and
must be physically present in the United States (21 CFR 1.227). FDA expects the facility
management to contact the person and confirm that the person is willing and able to serve as the
facility’s U.S. agent. The facility should “designate” a person as the facility’s U.S. agent only if
the person has affirmatively agreed to serve in that capacity. The person’s name and other
identifying information must be given in section 7 of Form FDA 3537 or in response to the
appropriate prompt when a facility is registered electronically. As previously stated in our
response to Question C.7.10, FDA will verify that the person identified as the U.S. agent for the
foreign facility has agreed to serve as the U.S. agent (see 21 CFR 1.231).