[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.15]



[Page 304]

 

                        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.