[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.15]

[Page 305-306]
 
                        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.

[[Page 306]]

    (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.