FDA 483 OBSERVATION · #17 OF 1,923 MOST-CITED
Food safety hazards
FDA cited this observation 878 times across 801 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 firm did not conduct an adequate hazard analysis — it failed to identify and evaluate the known or reasonably foreseeable biological, chemical (including radiological), and physical hazards that require a preventive control for each type of food it manufactures.
Why FDA writes it — The hazard analysis is the foundation of the entire preventive-controls system. If a real hazard is not identified, no preventive control is put in place for it — so a weak hazard analysis is the root of downstream control gaps.
- Identify and evaluate all known or reasonably foreseeable hazards for each type of food to determine whether any require a preventive control.
- Consider hazards that occur naturally, are unintentionally introduced, or may be intentionally introduced for economic gain, and evaluate severity and probability.
- Base the analysis on factors like the ingredients, process, packaging, storage, and intended use — and document the evaluation and its conclusions.
- Reanalyze the hazard analysis at least every three years, or when a change or new information warrants it.
- A generic hazard analysis copied across products without evaluating each food’s specific ingredients and process.
- Hazards dismissed without a documented rationale, leaving no preventive control for a hazard that was, in fact, reasonably foreseeable.
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 801 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 does not list the food safety hazards that are reasonably likely to occur.
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
Your HACCP plan does not list the food safety hazards that are 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 →