[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: 21CFR58.215]
 
[Page 321]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES--Table of Contents
 
            Subpart K--Disqualification of Testing Facilities
 
Sec. 58.215  Alternative or additional actions to disqualification.
 
    (a) Disqualification of a testing facility under this subpart is
independent of, and neither in lieu of nor a precondition to, other
proceedings or actions authorized by the act. The Food and Drug
Administration may, at any time, institute against a testing facility
and/or against the sponsor of a nonclinical laboratory study that has
been submitted to the Food and Drug Administration any appropriate
judicial proceedings (civil or criminal) and any other appropriate
regulatory action, in addition to or in lieu of, and prior to,
simultaneously with, or subsequent to, disqualification. The Food and
Drug Administration may also refer the matter to another Federal, State,
or local government law enforcement or regulatory agency for such action
as that agency deems appropriate.
    (b) The Food and Drug Administration may refuse to consider any
particular nonclinical laboratory study in support of an application for
a research or marketing permit, if it finds that the study was not
conducted in accordance with the good laboratory practice regulations
set forth in this part, without disqualifying the testing facility that
conducted the study or undertaking other regulatory action.