[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: 21CFR58.202]

[Page 314]
 
                        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.  58.202  Grounds for disqualification.

    The Commissioner may disqualify a testing facility upon finding all 
of the following:
    (a) The testing facility failed to comply with one or more of the 
regulations set forth in this part (or any other regulations regarding 
such facilities in this chapter);
    (b) The noncompliance adversely affected the validity of the 
nonclinical laboratory studies; and
    (c) Other lesser regulatory actions (e.g., warnings or rejection of 
individual studies) have not been or will probably not be adequate to 
achieve compliance with the good laboratory practice regulations.