[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: 21CFR1003.20]

[Page 578-579]
 
                        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 C--Notification
 
Sec. 1003.20  Notification by the manufacturer to the Secretary.


    The notification to the Secretary required by Sec. 1003.10(a) shall 
be confirmed in writing and, in addition to other relevant information 
which the Secretary may require, shall include the following:
    (a) Identification of the product or products involved;
    (b) The total number of such product units so produced, and the 
approximate number of such product units which have left the place of 
manufacture;

[[Page 579]]

    (c) The expected usage for the product if known to the manufacturer;
    (d) A description of the defect in the product or the manner in 
which the product fails to comply with an applicable Federal standard;
    (e) An evaluation of the hazards reasonably related to defect or the 
failure to comply with the Federal standard;
    (f) A statement of the measures to be taken to repair such defect or 
to bring the product into compliance with the Federal standard;
    (g) The date and circumstances under which the defect was 
discovered; and
    (h) The identification of any trade secret information which the 
manufacturer desires kept confidential.