FDA 483 OBSERVATION · #33 OF 1,923 MOST-CITED
Hazard analysis - Identification of hazard
FDA cited this observation 644 times across 592 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 hazard analysis failed to identify a food-safety hazard that is reasonably likely to occur — the analysis was absent, incomplete, or missed a hazard it should have identified for the product and process.
Why FDA writes it — Hazard identification is the foundation of HACCP: a hazard that is not identified gets no critical control point and no control. Missing a reasonably-likely hazard means the whole plan has a hole in it, which is why FDA scrutinises the identification step so closely.
- Conduct a hazard analysis that identifies the biological, chemical (including radiological), and physical hazards reasonably likely to occur for the specific product and process.
- Consider ingredients, process steps, packaging, storage, distribution, and intended use in the analysis.
- Document the hazards considered and the rationale for those included and excluded.
- Reassess the analysis when the product, process, or hazard information changes.
- A generic hazard analysis reused across products without evaluating each product’s specific hazards.
- A real hazard excluded without a documented, science-based 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 1.2× the rate of the average FDA-cited firm (9.5% vs 7.8%), across 592 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 hazard analysis did not identify a hazard that required a preventive control.
Your hazard analysis did not identify a hazard that required a preventive control.
Your hazard analysis did not identify a hazard that required a preventive control.
Your hazard analysis did not identify a hazard that required a preventive control.
Your hazard analysis did not identify a hazard that required a preventive control.
Your hazard analysis did not identify a hazard that required a preventive control.
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 →