After you submit your registration, FDA will verify that the person identified as the U.S. agent
for your foreign facility has agreed to serve as your U.S. agent. FDA will not confirm your
registration or provide you with a registration number until that person confirms that the
person has agreed to serve as your U.S. agent (see 21 CFR 1.231(a)(5) and (b)(7)).
If the person listed as the U.S. agent informs FDA that the person has not agreed to serve as the
facility’s U.S. agent, FDA will inform the facility (through its owner, operator, or agent in
charge) of that fact and request that the facility amend the registration to designate a person that
has in fact agreed to serve as the facility’s U.S. agent.
