If someone agrees to be the U.S. agent for a foreign facility and later wishes to be removed as the U.S. agent, how would this be accomplished? What is the status of the facility’s registration?

To ensure that FDA is aware of the U.S. agent’s intention of being removed from the facility’s
registration, the U.S. agent may notify FDA of its intention by sending an e-mail to
FURLS@FDA.gov. This e-mail should include the information previously provided on the
registration form regarding the U.S. agent (i.e., name, address, phone number, email address) and
the name(s) and either address(es) or registration number(s) of the facility or facilities from which
the U.S. agent wishes to be removed. The owner, operator, or agent in charge of the foreign
facility, or an individual authorized by one of them (e.g., the U.S. agent), must update the
information identifying the facility’s U.S. agent in the facility’s registration (21 CFR 1.234). FDA
will then notify the facility (through its owner, operator, or agent in charge) within 60 calendar
days of the removal and request that the facility amend the registration to designate another U.S.
agent who has in fact agreed to serve as the facility’s U.S. agent