[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: 21CFR58.219]



[Page 314-315]

 

                        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.  58.219  Reinstatement of a disqualified testing facility.



    A testing facility that has been disqualified may be reinstated as 

an acceptable source of nonclinical laboratory studies to be submitted 

to the Food and Drug Administration if the Commissioner determines, upon 

an evaluation of the submission of the testing facility, that the 

facility can adequately assure that it will conduct future nonclinical 

laboratory studies in compliance with the good laboratory practice 

regulations set forth in this part and, if any studies are currently 

being conducted, that the quality and integrity of such studies have not 

been seriously compromised. A disqualified testing facility that wishes 

to be so reinstated shall present in writing to the Commissioner reasons 

why it believes it should be reinstated and a detailed description of 

the corrective actions it has taken or intends to take to assure that 

the acts or omissions which led to its disqualification will not recur. 

The Commissioner may condition reinstatement upon the testing facility 

being found in compliance with the good laboratory practice regulations 

upon an inspection. If a testing facility is reinstated, the 

Commissioner shall so notify the testing facility and all organizations 

and persons who were notified, under Sec.  58.213 of the 

disqualification of the testing facility. A determination that a testing 

facility has



[[Page 315]]



been reinstated is disclosable to the public under part 20 of this 

chapter.