[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.34]
 
[Page 435]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 80--COLOR ADDITIVE CERTIFICATION--Table of Contents
 
                   Subpart B--Certification Procedures
 
Sec. 80.34  Authority to refuse certification service.
 
    (a) When it appears to the Commissioner that a person has:
    (1) Obtained, or attempted to obtain, a certificate through fraud or
misrepresentation of a material fact.
    (2) Falsified the records required to be kept by Sec. 80.39; or
    (3) Failed to keep such records, or to make them available, or to
accord full opportunity to make inventory of stocks on hand or otherwise
to check the correctness of such records, as required by Sec. 80.39; or
    (4) Refused to permit duly authorized employees of the Food and Drug
Administration free access to all manufacturing facilities, processes,
and formulae involved in the manufacture of color additives and
intermediates from which such color additives are derived; he may
immediately suspend certification service to such person and may
continue such suspension until adequate corrective action has been
taken.
    (b) Any person who contests suspension of service shall have an
opportunity for a regulatory hearing before the Food and Drug
Administration pursuant to part 16 of this chapter.