[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.241]

[Page 24-25]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
                Subpart H_Registration of Food Facilities
 
Sec.  1.241  What are the consequences of failing to register, update, or cancel your registration?

    (a) Section 301 of the act (21 U.S.C. 331) prohibits the doing of 
certain acts or causing such acts to be done. Under section 302 of the 
act (21 U.S.C. 332), the United States can bring a civil action in 
Federal court to enjoin a person who commits a prohibited act. Under 
section 303 of the act (21 U.S.C. 333),

[[Page 25]]

the United States can bring a criminal action in Federal court to 
prosecute a person who is responsible for the commission of a prohibited 
act. Under section 306 of the act (21 U.S.C. 335a), FDA can seek 
debarment of any person who has been convicted of a felony relating to 
importation of food into the United States. Failure of an owner, 
operator, or agent in charge of a domestic or foreign facility to 
register its facility, to update required elements of it's facility's 
registration, or to cancel its registration in accordance with the 
requirements of this subpart is a prohibited act under section 301(dd) 
of the act.
    (b) FDA will cancel a registration if the agency independently 
verifies that the facility is no longer in business or has changed 
owners, and the owner, operator, or agent in charge of the facility 
fails to cancel the registration, or if FDA determines that the 
registration is for a facility that does not exist. If FDA cancels a 
facility's registration, FDA will mail a confirmation of the 
cancellation to the facility at the address provided in the facility's 
registration.
    (c) If an article of food is imported or offered for import into the 
United States and a foreign facility that manufactured/processed, 
packed, or held that article of food has not registered in accordance 
with this subpart, the disposition of the article of food shall be 
governed by the procedures set out in subpart I of this part.