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: 21CFR58.15]
[Page 311]
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 A--General Provisions
Sec. 58.15 Inspection of a testing facility.
(a) A testing facility shall permit an authorized employee of the
Food and Drug Administration, at reasonable times and in a reasonable
manner, to inspect the facility and to inspect (and in the case of
records also to copy) all records and specimens required to be
maintained regarding studies within the scope of this part. The records
inspection and copying requirements shall not apply to quality assurance
unit records of findings and problems, or to actions recommended and
taken.
(b) The Food and Drug Administration will not consider a nonclinical
laboratory study in support of an application for a research or
marketing permit if the testing facility refuses to permit inspection.
The determination that a nonclinical laboratory study will not be
considered in support of an application for a research or marketing
permit does not, however, relieve the applicant for such a permit of any
obligation under any applicable statute or regulation to submit the
results of the study to the Food and Drug Administration.