[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271]

[Page 736-737]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table 
 
 Subpart F_Inspection and Enforcement of Establishments Described in   
                                 1271.10
 
Sec.  1271.400  Inspections.

    (a) If you are an establishment that manufactures HCT/Ps described 
in Sec.  1271.10, whether or not under contract, you must permit the 
Food and Drug Administration (FDA) to inspect any manufacturing location 
at any reasonable time and in a reasonable manner to determine 
compliance with applicable provisions of this part. The inspection will 
be conducted as necessary in

[[Page 737]]

the judgment of the FDA and may include your establishment, facilities, 
equipment, finished and unfinished materials, containers, processes, 
HCT/Ps, procedures, labeling, records, files, papers, and controls 
required to be maintained under the part. The inspection may be made 
with or without prior notification and will ordinarily be made during 
regular business hours.
    (b) The frequency of inspection will be at the agency's discretion.
    (c) FDA will call upon the most responsible person available at the 
time of the inspection of the establishment and may question the 
personnel of the establishment as necessary to determine compliance with 
the provisions of this part.
    (d) FDA's representatives may take samples, may review and copy any 
records required to be kept under this part, and may use other 
appropriate means to record evidence of observations during inspections 
conducted under this subpart.
    (e) The public disclosure of records containing the name or other 
positive identification of donors or recipients of HCT/Ps will be 
handled in accordance with FDA's procedures on disclosure of information 
as set forth in parts 20 and 21 of this chapter.