This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[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: 21CFR58.202]
[Page 320]
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. 58.202 Grounds for disqualification.
The Commissioner may disqualify a testing facility upon finding all
of the following:
(a) The testing facility failed to comply with one or more of the
regulations set forth in this part (or any other regulations regarding
such facilities in this chapter);
(b) The noncompliance adversely affected the validity of the
nonclinical laboratory studies; and
(c) Other lesser regulatory actions (e.g., warnings or rejection of
individual studies) have not been or will probably not be adequate to
achieve compliance with the good laboratory practice regulations.