[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: 21CFR1003.10]

[Page 564]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 1003--NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY--Table of Contents
 
           Subpart B--Discovery of Defect or Failure to Comply
 
Sec. 1003.10  Discovery of defect or failure of compliance by manufacturer; notice requirements.


    Any manufacturer who discovers that any electronic product produced, 
assembled, or imported by him, which product has left its place of 
manufacture, has a defect or fails to comply with an applicable Federal 
standard shall:
    (a) Immediately notify the Secretary in accordance with 
Sec. 1003.20, and
    (b) Except as authorized by Sec. 1003.30, furnish notification with 
reasonable promptness to the following persons:
    (1) The dealers or distributors to whom such product was delivered 
by the manufacturer; and
    (2) The purchaser of such product and any subsequent transferee of 
such product (where known to the manufacturer or where the manufacturer 
upon reasonable inquiry to dealers, distributors, or purchasers can 
identify the present user).
    (c) If a manufacturer is required to notify the Secretary under 
paragraph (a) of this section and also is required to report to the Food 
and Drug Administration under part 803 of this chapter, the manufacturer 
shall report in accordance with part 803. If a manufacturer is required 
to notify the Secretary under paragraph (a) of this section and is not 
required to report to the Food and Drug Administration under part 803, 
the manufacturer shall notify the Secretary in accordance with paragraph 
(a) of this section.

[38 FR 28628, Oct. 15, 1973 and 49 FR 36351, Sept. 14, 1984]