[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: 21CFR58.219]

[Page 316]
 
                        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 
 
            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 been reinstated is disclosable to the public under part 20 
of this chapter.