---
kind: "section"
citation: "21 C.F.R. § 507.42"
title: "21"
number: "507.42"
heading: "Corrective actions and corrections."
url: "https://uscodex.org/cfr/21/507.42"
---

# §507.42. Corrective actions and corrections.

- (a) As appropriate to the nature of the hazard and the nature of the preventive control, except as provided by [paragraph (c)](#c) of this section:
  - (1) You must establish and implement written corrective action procedures that must be taken if preventive controls are not properly implemented, including procedures to address, as appropriate:
    - (i) The presence of a pathogen or appropriate indicator organism in animal food detected as a result of product testing conducted in accordance with [§ 507.49(a)(2)](/cfr/21/507.49.md?p=a-2); and
    - (ii) The presence of an environmental pathogen or appropriate indicator organism detected through the environmental monitoring conducted in accordance with [§ 507.49(a)(3)](/cfr/21/507.49.md?p=a-3).
  - (2) The corrective action procedures must describe the steps to be taken to ensure that:
    - (i) Appropriate action is taken to identify and correct a problem that has occurred with implementation of a preventive control;
    - (ii) Appropriate action is taken when necessary, to reduce the likelihood that the problem will recur;
    - (iii) All affected animal food is evaluated for safety; and
    - (iv) All affected animal food is prevented from entering into commerce if you cannot ensure the affected animal food is not adulterated under [section 402](/cfr/21/402.md) of the Federal Food, Drug, and Cosmetic Act.
- (b)
  - (1) Except as provided by [paragraph (c)](#c) of this section, you are subject to the requirements of [paragraph (b)(2)](#b-2) of this section if any of the following circumstances apply:
    - (i) A preventive control is not properly implemented and a corrective action procedure has not been established;
    - (ii) A preventive control, combination of preventive controls, or the food safety plan as a whole is found to be ineffective; or
    - (iii) A review of records in accordance with [§ 507.49(a)(4)](/cfr/21/507.49.md?p=a-4) finds that the records are not complete, the activities conducted did not occur in accordance with the food safety plan, or appropriate decisions were not made about corrective actions.
  - (2) If any of the circumstances listed in [paragraph (b)(1)](#b-1) of this section apply, you must:
    - (i) Take corrective action to identify and correct the problem;
    - (ii) Reduce the likelihood that the problem will recur;
    - (iii) Evaluate all affected animal food for safety;
    - (iv) As necessary, prevent affected animal food from entering commerce as would be done following the corrective action procedure under [paragraph (a)(2)](#a-2) of this section; and
    - (v) When appropriate, reanalyze the food safety plan in accordance with [§ 507.50](/cfr/21/507.50.md) to determine whether modification of the food safety plan is required.
- (c) **You do not need to comply with the requirements of paragraphs (a) and (b) of this section if—**
  - (1) You take action, in a timely manner, to identify and correct conditions and practices that are not consistent with the sanitation controls in § [507.34(c)(2)(i)](/cfr/21/507.34.md?p=c-2-i) or [(ii)](/cfr/21/507.34.md?p=c-2-ii); or
  - (2) You take action, in a timely manner, to identify and correct a minor and isolated problem that does not directly impact product safety.
- (d) All corrective actions (and, when appropriate, corrections) taken in accordance with this section must be documented in records. These records are subject to verification in accordance with [§ 507.45(a)(3)](/cfr/21/507.45.md?p=a-3) and records review in accordance with [§ 507.49(a)(4)(i)](/cfr/21/507.49.md?p=a-4-i).

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56337, Sept. 17, 2015, unless otherwise noted.