[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1270.41]

[Page 681]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1270--HUMAN TISSUE INTENDED FOR TRANSPLANTATION--Table of Contents
 
             Subpart D--Inspection of Tissue Establishments
 
Sec. 1270.41  Inspections.


    (a) An establishment covered by these regulations in this part, 
including any location performing contract services, shall permit an 
authorized inspector of the Food and Drug Administration (FDA) to make 
at any reasonable time and in a reasonable manner such inspection of the 
establishment, its facilities, equipment, processes, products, and 
records as may be necessary to determine compliance with the provisions 
of this part. Such inspections may be made with or without notice and 
will ordinarily be made during regular business hours.
    (b) The frequency of inspection will be at the agency's discretion.
    (c) The inspector shall call upon a responsible person of the 
establishment and may question the personnel of the establishment as the 
inspector deems necessary.
    (d) The inspector may review and copy any records required to be 
kept pursuant to part 1270.
    (e) The public disclosure of records containing the name or other 
positive identification of donors or recipients of human tissue will be 
handled in accordance with FDA's procedures on disclosure of information 
as set forth in 21 CFR part 20 of this chapter.