We anticipate that in many cases it will be appropriate for FDA to send notices to facilities
facing potential cancellation indicating our intent to cancel their registrations and the basis for
such cancellations. We also anticipate that, when appropriate, if the circumstances meriting
possible cancellation are corrected within 30 days after notice is provided, we will not cancel the
registration. We further anticipate that if facilities do not respond within 30 days, or if corrective
action is otherwise not taken within that time period, we will consider the lack of response or
lack of corrective action as independent verification that the facility should no longer be
registered and will then cancel the registration. If a facility believes its registration was cancelled
in error, the facility may contact FDA. We also anticipate that it will generally not be
appropriate to provide the 30-day window for corrective action if the basis for cancellation is an
expired registration due to failure to renew a registration in accordance with 21 CFR 1.230(b). In
those circumstances, a facility would have already received notice of its obligation to renew.
Leading up to and throughout the registration renewal period, we plan to notify registrants of
their obligation to renew registrations and the deadline for doing so. We also plan to notify
registrants that failure to renew their registrations in accordance with 21 CFR 1.230(b) will cause
FDA to consider the registrations expired. Additionally, we plan to notify registrants that we
will consider a food facility with an expired registration to have failed to register in accordance
with section 415 of the FD&C Act.
If FDA cancels a facility’s registration, FDA will send a confirmation of the cancellation to the
facility (see 21 CFR 1.241(c)).
