21 CFR 123.7: Corrective actions
Requires seafood processors to respond to any critical limit deviation by following a predetermined corrective action plan or, absent one, segregating and evaluating product, fixing the cause, reassessing the HACCP plan, and documenting everything.
Part 123, Fish and Fishery Products · Subpart A, General Provisions
How FDA words it
The opening lines investigators use most when they cite 123.7, from the 483s we hold.
You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.Most used
Recent 483s citing 123.7
- JFC International, Inc · Coppell, TexasYou did not take corrective action that ensured affected product was not entered… Feb 20, 2026
- Dendreon Pharmaceuticals LLC · Union City, GeorgiaYou do not have records that document corrective actions that were taken… Oct 22, 2018
- Haifa Smoked Fish, Inc. · Jamaica, New YorkYou did not take corrective action that ensured affected product was not entered… Jul 5, 2006
- Haifa Smoked Fish, Inc. · Jamaica, New YorkYou did not take cOITective action that ensured affected product was not entered… Oct 7, 2005
- Haifa Smoked Fish, Inc. · Jamaica, New YorkYou did not take corrective action that ensured affected product was not entered… Jul 20, 2005
The regulation text
§ 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 § 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 § 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 § 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 § 123.8(a)(3)(ii) and the recordkeeping requirements of § 123.9.
Questions
What does 21 CFR 123.7 require?
Requires seafood processors to respond to any critical limit deviation by following a predetermined corrective action plan or, absent one, segregating and evaluating product, fixing the cause, reassessing the HACCP plan, and documenting everything.
How do FDA investigators word a 123.7 observation?
The most common opening is: “You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.”
Which sections are cited alongside 123.7?
In the same 483s, investigators most often also cite 123.11 (Sanitation control procedures), 123.6 (Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan), 123.8 (Verification), 123.9 (Records).