[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1002.31]

[Page 561]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 1002--RECORDS AND REPORTS--Table of Contents
 
                    Subpart D--Manufacturers' Records
 
Sec. 1002.31  Preservation and inspection of records.

    (a) Every manufacturer required to maintain records pursuant to this 
part, including records received pursuant to Sec. 1002.41, shall 
preserve such records for a period of 5 years from the date of the 
record.
    (b) Upon reasonable notice by an officer or employee duly designated 
by the Department, manufacturers shall permit such officer or employee 
to inspect appropriate books, records, papers, and documents as are 
relevant to determining whether the manufacturer has acted or is acting 
in compliance with Federal standards.
    (c) Upon request of the Director, Center for Devices and 
Radiological Health, a manufacturer of products listed in table 1 of 
Sec. 1002.1 shall submit to the Director, copies of the records required 
to be maintained by paragraph (b) of Sec. 1002.30.

[38 FR 28625, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 60 
FR 48386, Sept. 19, 1995]