[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR226.115]

[Page 175]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 226_CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES--Table of Contents
 
                      Subpart E_Records and Reports
 
Sec.  226.115  Complaint files.

    Records shall be maintained for a period of 2 years of all written 
or verbal complaints concerning the safety or efficacy of each Type A 
medicated article(s). Complaints shall be evaluated by competent and 
responsible personnel and, where indicated, appropriate action shall be 
taken. The record shall indicate the evaluation and the action.