[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: 21CFR58.219]

[Page 321-322]
 
                        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

[[Page 322]]

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.