FDA 483 OBSERVATION · #49 OF 1,923 MOST-CITED
Corrective action plan
FDA cited this observation 497 times across 437 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
What this observation means, and how to comply
SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.
The HACCP plan lacked adequate corrective-action procedures, or corrective actions were not taken (or not recorded) when a deviation from a critical limit occurred — so a loss of control was not properly addressed.
Why FDA writes it — Corrective actions determine what happens to the process and the affected product when a critical limit is breached. Without them, a deviation leaves potentially unsafe product uncontrolled and the cause uncorrected, which is exactly the situation HACCP exists to prevent.
- Establish corrective-action procedures to be taken when a deviation from a critical limit occurs.
- Ensure corrective actions address both the affected product (identify, segregate, evaluate, disposition) and the cause of the deviation.
- Record every corrective action taken, including the deviation and the disposition of affected product.
- Reassess the plan where deviations recur, to see whether the CCP or limit needs changing.
- No predefined corrective-action procedure, so responses are improvised and product control is inconsistent.
- Corrective action addresses the product but never the cause, so the deviation recurs.
How to close this finding — and stop it recurring
What this observation is associated with
Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.5× the rate of the average FDA-cited firm (11.4% vs 7.8%), across 437 FEI-matched firms.
This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.
How FDA worded it — real examples
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure.
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure the cause of the deviation was corrected.
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure the cause of the deviation was corrected.
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure the cause of the deviation was corrected.
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure affected product is not entered into commerce.
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure affected product is not entered into commerce and the cause of the deviation was corrected.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →