[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR17.5]

[Page 174]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 17_CIVIL MONEY PENALTIES HEARINGS--Table of Contents
 
Sec.  17.5  Complaint.

    (a) The Center with principal jurisdiction over the matter involved 
shall begin all administrative civil money penalty actions by serving on 
the respondent(s) a complaint signed by the Office of the Chief Counsel 
attorney for the Center and by filing a copy of the complaint with the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (b) The complaint shall state:
    (1) The allegations of liability against the respondent, including 
the statutory basis for liability, the identification of violations that 
are the basis for the alleged liability, and the reasons that the 
respondent is responsible for the violations;
    (2) The amount of penalties and assessments that the Center is 
seeking;
    (3) Instructions for filing an answer to request a hearing, 
including a specific statement of the respondent's right to request a 
hearing by filing an answer and to retain counsel to represent the 
respondent; and
    (4) That failure to file an answer within 30 days of service of the 
complaint will result in the imposition of the proposed amount of 
penalties and assessments, as provided in Sec.  17.11.
    (c) The Center may, on motion, subsequently amend its complaint to 
conform with the evidence adduced during the administrative process, as 
justice may require.
    (d) The presiding officer will be assigned to the case upon the 
filing of the complaint under this part.