[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.
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