[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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), 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



[[Page 25]]



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.