[Title 21 CFR I]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 820 - QUALITY SYSTEM REGULATION]
[Subpart I - Nonconforming Product]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS81999-04-011999-04-01falseISubpart IFOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICESQUALITY SYSTEM REGULATION
                    Subpart I--Nonconforming Product



Sec. 820.90  Nonconforming product.

    (a) Control of nonconforming product. Each manufacturer shall 
establish and maintain procedures to control product that does not 
conform to specified requirements. The procedures shall address the 
identification, documentation, evaluation, segregation, and disposition 
of nonconforming product. The evaluation of nonconformance shall include 
a determination of the need for an investigation and notification of the 
persons or organizations responsible for the nonconformance. The 
evaluation and any investigation shall be documented.
    (b) Nonconformity review and disposition. (1) Each manufacturer 
shall establish and maintain procedures that define the responsibility 
for review and the authority for the disposition of nonconforming 
product. The procedures shall set forth the review and disposition 
process. Disposition of nonconforming product shall be documented. 
Documentation shall include the justification for use of nonconforming 
product and the signature of the individual(s) authorizing the use.
    (2) Each manufacturer shall establish and maintain procedures for 
rework, to include retesting and reevaluation of the nonconforming 
product after rework, to ensure that the product meets its current 
approved specifications. Rework and reevaluation activities, including a 
determination of any adverse effect from the rework upon the product, 
shall be documented in the DHR.