[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.
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