For registrations or registration renewals not submitted by the owner, operator, or agent in charge
of the facility, FDA will verify that the individual identified as having authorized the submission
in fact authorized the submission on behalf of the facility. FDA will not confirm a registration,
provide a registration number, or provide confirmation of a registration renewal until that
individual confirms that he or she authorized the submission (see 21 CFR 1.231(a)(4) and (b)(6)).
In most circumstances, FDA will conduct this verification step by sending an email to the
individual identified as having authorized the submission. 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.
For updates and cancellations, FDA will not provide a confirmation of the registration update or
cancellation until the individual confirms that he or she authorized the submission (21 CFR
1.234(c)(3) and (d)(6) (for updates) and 1.235(c)(3) and (d)(6) (for cancellations)). We will
provide the owner, operator, or agent in charge of the facility 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, update, or cancellation submission will be removed from our database and a
new submission will be required. For registration renewals, updates, or cancellations, if FDA has
previously verified that the authorizing individual has authorized the individual submitting the
renewal to make registration submissions on behalf of the facility, FDA will not re-verify that the
authorizing individual in fact authorized the submission.
FDA will continue its current practice of individually contacting facilities if specific questions
arise regarding the facility’s registration.
