[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR225.115]

[Page 142-143]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS--Table of Contents
 
                     Subpart E--Records and Reports
 
Sec. 225.115  Complaint files.

    (a) Complaints and reports of experiences of product defects 
relative to the drug's efficacy or safety may provide an indicator as to 
whether or not medicated feeds have been manufactured in conformity with 
current good manufacturing practices. These complaints and experiences 
may reveal the existence of manufacturing problems not otherwise 
detected through the normal quality control procedures. Timely and 
appropriate follow-up action can serve to correct a problem and minimize 
future problems.
    (b) The medicated feed manufacturer shall maintain on the premises a 
file which contains the following information:
    (1) The original or copy of a record of each oral and written 
complaint received relating to the safety and effectiveness of the 
product produced. The record shall include the date of the complaint, 
the complainant's name and address, name and lot or control number or 
date of manufacture of the medicated feed involved, and the specific 
details of the complaint. This record shall also include all 
correspondence

[[Page 143]]

from the complainant and/or memoranda of conversations with the 
complainant, and a description of all investigations made by the 
manufacturer and of the method of disposition of the complaint.
    (2) For medicated feeds whose manufacture require a medicated feed 
mill license (Form FDA 3448), records and reports of clinical and other 
experience with the drug shall be maintained and reported, under 
Sec. 510.301 of this chapter.

[41 FR 52618, Nov. 30, 1976, as amended at 51 FR 7390, Mar. 3, 1986; 57 
FR 6475, Feb. 25, 1992; 64 FR 63203, Nov. 19, 1999]