FDA 483 OBSERVATION · #37 OF 1,923 MOST-CITED
Hazard analysis biological, chemical, physical
FDA cited this observation 592 times across 523 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 did not adequately consider the biological, chemical (including radiological), and physical hazard categories — one or more hazard types was overlooked for the food and process.
Why FDA writes it — Hazards come in distinct categories, and missing a category leaves an entire class of risk uncontrolled. FDA cites this when an analysis addresses, say, microbial hazards but overlooks chemical (allergen, residue) or physical (foreign-object) hazards.
- Evaluate biological, chemical (including radiological), and physical hazards for each type of food.
- Include hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced for economic gain.
- Consider allergens as a chemical hazard where applicable.
- Document the evaluation across all hazard categories, not just the obvious ones.
- Focusing on microbial hazards and overlooking chemical (allergen/residue) or physical hazards.
- Not considering the food’s specific ingredients and process when identifying hazard types.
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 2× the rate of the average FDA-cited firm (15.9% vs 7.8%), across 523 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 requires a control.
Your hazard analysis did not identify a hazard that requires a control.
Your hazard analysis did not identify a hazard that requires a control.
Your hazard analysis did not identify a hazard that requires a control.
Your hazard analysis did not identify a hazard that requires a control.
Your hazard analysis did not identify a hazard that requires a 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 →