[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR821.50]

[Page 156]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                   Subpart D--Records and Inspections
 
Sec. 821.50  Availability.


    (a) Manufacturers, distributors, multiple distributors, and final 
distributors shall, upon the presentation by an FDA representative of 
official credentials and the issuance of Form FDA 482 at the initiation 
of an inspection of an establishment or person under section 704 of the 
act, make each record and all information required to be collected and 
maintained under this part and all records and information related to 
the events and persons identified in such records available to FDA 
personnel.
    (b) Records and information referenced in paragraph (a) of this 
section shall be available to FDA personnel for purposes of reviewing, 
copying, or any other use related to the enforcement of the act and this 
part. Records required to be kept by this part shall be kept in a 
centralized point for each manufacturer or distributor within the United 
States.

[58 FR 43447, Aug. 16, 1993, as amended at 65 FR 43690, July 14, 2000]