[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: 21CFR58.202]



[Page 312]

 

                        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.



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