The failure to register your facility, update required elements, or cancel a registration in accordance with 21 CFR Part 1, Subpart H is a prohibited act under the FD&C Act (see 21 C.F.R. 1.241). If a foreign food facility is required to register with FDA, but fails to do so, food from that facility that is being imported or offered for import into the U.S. is subject to refusal under section 801(l) of the FD&C Act.
