[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR123.7]

[Page 278]
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 123_FISH AND FISHERY PRODUCTS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 123.7  Corrective actions.

    (a) Whenever a deviation from a critical limit occurs, a processor 
shall take corrective action either by:
    (1) Following a corrective action plan that is appropriate for the 
particular deviation, or
    (2) Following the procedures in paragraph (c) of this section.
    (b) Processors may develop written corrective action plans, which 
become part of their HACCP plans in accordance with Sec. 123.6(c)(5), 
by which they 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.
    (c) 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 (c)(2) and (c)(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 a review. Adequate training may or may not include training 
in accordance with Sec. 123.10;
    (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;
    (5) Perform or obtain timely reassessment by an individual or 
individuals who have been trained in accordance with Sec. 123.10, to 
determine whether the HACCP plan needs to be modified to reduce the risk 
of recurrence of the deviation, and modify the HACCP plan as necessary.
    (d) All corrective actions taken in accordance with this section 
shall be fully documented in records that are subject to verification in 
accordance with Sec. 123.8(a)(3)(ii) and the recordkeeping requirements 
of Sec. 123.9.