FDA 483 OBSERVATION · #35 OF 1,923 MOST-CITED
No HACCP plan
FDA cited this observation 624 times across 576 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.
A processor required to have a HACCP plan did not have one for a product/hazard where the hazard analysis identified a food-safety hazard reasonably likely to occur — the plan simply did not exist.
Why FDA writes it — For seafood and juice, HACCP is the mandatory food-safety framework. When a required HACCP plan is absent, the identified hazards are, by definition, not being systematically controlled — so FDA cites the missing plan as a fundamental failure, not a paperwork gap.
- Conduct a hazard analysis and, where it identifies a hazard reasonably likely to occur, develop and implement a written HACCP plan.
- Ensure the plan covers each such hazard with critical control points, critical limits, monitoring, corrective actions, verification, and recordkeeping.
- Have the plan signed and dated by the responsible individual, and reassess it as required.
- Where the analysis identifies no hazards reasonably likely to occur, document that determination.
- A hazard analysis was never performed, so the need for a plan was never recognised.
- A hazard reasonably likely to occur was judged away without a documented, defensible rationale.
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 (11.6% vs 7.8%), across 576 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
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.
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 →