[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: 21CFR58.15]

[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 
 
                      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

[[Page 306]]

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.