[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.10]
[Page 269-270]
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
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;
[[Page 270]]
(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 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.
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