For registrations, registration renewals, and updates to information about U.S. agents, FDA will verify that the person identified as the U.S. agent for the foreign facility agreed to serve as the U.S. agent (see 21 CFR 1.231(a)(5) and (b)(7) (for registrations and registration renewals) and 1.234(c)(2) and (d)(5) (for updates)). FDA will not confirm a registration or registration Contains Nonbinding Recommendations 42 renewal or provide a registration number until the person identified as the U.S. agent for the foreign facility confirms that the person agreed to serve as the U.S. agent (21 CFR 1.231(a)(5) and (b)(6)). For updates, FDA will not provide a confirmation of the registration update until the person identified as the U.S. agent for the foreign facility confirms that the person agreed to serve as the U.S. agent (21 CFR 1.234(c)(2) and (d)(5)).
In most circumstances, FDA will conduct this verification step by sending an email to the person identified as the U.S. agent. In some circumstances, however, FDA may determine that it is appropriate to use other methods to conduct the verification step, such as U.S. mail or phone. If the individual listed as the U.S. agent informs FDA that he 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 an individual who has agreed to serve as the facility’s U.S. agent. For registration renewals, if FDA has previously verified that the U.S. agent has agreed to serve as the U.S. agent for the facility, FDA will not re-verify that the U.S. agent has agreed to serve as the U.S. agent for the foreign facility. We will provide the person identified as the U.S. agent 30 calendar days to respond to our verification request. If we do not receive a response to our verification request within that time, the registration, registration renewal, or update submission will be removed from our database and a new submission will be required.
