---
kind: "section"
citation: "21 C.F.R. § 120.10"
title: "21"
number: "120.10"
heading: "Corrective actions."
url: "https://uscodex.org/cfr/21/120.10"
---

# §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)](#a) or [paragraph (b)](#b) of this section.

- (a) Processors may develop written corrective action plans, which become part of their HACCP plans in accordance with [§ 120.8(b)(5)](/cfr/21/120.8.md?p=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)](#b-2) and [(b)(3)](#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 [§ 120.11](/cfr/21/120.11.md), by an individual or individuals who have been trained in accordance with [§ 120.13](/cfr/21/120.13.md), 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 [§ 120.11(a)(1)(iv)(B)](/cfr/21/120.11.md?p=a-1-iv-B) and the recordkeeping requirements of [§ 120.12](/cfr/21/120.12.md).

## Notes

### Authority

Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264.

### Source

Source: 66 FR 6197, Jan. 19, 2001, unless otherwise noted.