[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: 21CFR820.22]

[Page 141-142]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 820--QUALITY SYSTEM REGULATION--Table of Contents
 
                 Subpart B--Quality System Requirements
 
Sec. 820.22  Quality audit.

    Each manufacturer shall establish procedures for quality audits and 
conduct such audits to assure that the quality system is in compliance 
with the established quality system requirements and to determine the 
effectiveness of the quality system. Quality audits shall be conducted 
by individuals who do not have direct responsibility for the matters 
being audited. Corrective action(s), including a reaudit of deficient 
matters, shall be taken when necessary. A report of the results of

[[Page 142]]

each quality audit, and reaudit(s) where taken, shall be made and such 
reports shall be reviewed by management having responsibility for the 
matters audited. The dates and results of quality audits and reaudits 
shall be documented.