What are the consequences if an owner, operator, or agent in charge of a facility does not register, renew, update, or cancel the facility’s registration, as required in section 415 of the FD&C Act and 21 CFR part 1, subpart H?

If a facility is required to register under section 415 of the FD&C Act, then the failure of an
owner, operator, or agent in charge of a facility to register its facility, renew the registration of its
facility, update required registration elements of its facility’s registration, or to cancel its
registration in accordance with the requirements in 21 CFR part 1, subpart H is a prohibited act
under section 301(dd) of the FD&C Act (21 U.S.C. 331(dd)). See 21 CFR 1.241(a). The United
States can bring a civil action in Federal court to enjoin a person who commits a prohibited act.
The United States also can bring a criminal action in Federal court to prosecute a person who is
responsible for the commission of a prohibited act (21 CFR 1.241(a)). In addition, under section
306 of FD&C Act, FDA can seek debarment of any person who has been convicted of a felony
relating to importation of food into the United States.
If food being imported or offered for import into the United States is from a foreign facility for
which registration has not been submitted, the food must be held at the port of entry and may not
be delivered to the importer, owner, or consignee of the food until the foreign facility is
registered. However, the food may be directed to a secure facility by FDA and/or U.S. Customs
and Border Protection (CBP) (section 801(l) of the FD&C Act).