[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.