[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.10]

[Page 263-264]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 120.10  Corrective actions.

    Whenever a deviation from a critical limit occurs, a processor shall 
take corrective action by following the procedures set forth in 
paragraph (a) or paragraph (b) of this section.
    (a) Processors may develop written corrective action plans, which 
become part of their HACCP plans in accordance with Sec. 120.8(b)(5), by 
which processors predetermine the corrective actions that they will take 
whenever there is a deviation from a critical limit. A corrective action 
plan that is appropriate for a particular deviation is one that 
describes the steps to be taken and assigns responsibility for taking 
those steps, to ensure that:
    (1) No product enters commerce that is either injurious to health or 
is otherwise adulterated as a result of the deviation; and
    (2) The cause of the deviation is corrected.
    (b) When a deviation from a critical limit occurs, and the processor 
does not have a corrective action plan that is appropriate for that 
deviation, the processor shall:
    (1) Segregate and hold the affected product, at least until the 
requirements of paragraphs (b)(2) and (b)(3) of this section are met;
    (2) Perform or obtain a review to determine the acceptability of the 
affected product for distribution. The review shall be performed by an 
individual or individuals who have adequate training or experience to 
perform such review;
    (3) Take corrective action, when necessary, with respect to the 
affected product to ensure that no product enters commerce that is 
either injurious to health or is otherwise adulterated as a result of 
the deviation;
    (4) Take corrective action, when necessary, to correct the cause of 
the deviation; and
    (5) Perform or obtain timely verification in accordance with 
Sec. 120.11, by an individual or individuals who

[[Page 264]]

have been trained in accordance with Sec. 120.13, to determine whether 
modification of the HACCP plan is required to reduce the risk of 
recurrence of the deviation, and to modify the HACCP plan as necessary.
    (c) All corrective actions taken in accordance with this section 
shall be fully documented in records that are subject to verification in 
accordance with Sec. 120.11(a)(1)(iv)(B) and the recordkeeping 
requirements of Sec. 120.12.