FDA 483 OBSERVATION · #106 OF 1,923 MOST-CITED
Document review entity's hazard analysis
FDA cited this observation 283 times across 274 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.
Under FSVP the importer must analyze the hazards in each food to determine which require a control; where the importer relies on the foreign supplier’s or another entity’s hazard analysis, it must review and assess that document rather than accept it blindly.
Why FDA writes it — FDA cites this when the importer never obtained or evaluated the hazard analysis it depends on, so it cannot know which hazards need control — the entire FSVP program is built on a hazard analysis the importer has not actually reviewed.
- Obtain the hazard analysis you rely on and have a qualified individual review it for completeness against biological, chemical, and physical hazards.
- Confirm the analysis identifies who controls each hazard requiring a control before you rely on it.
- Document your review and reconcile any hazards the entity’s analysis missed by performing or supplementing the analysis yourself.
- Accepting a supplier’s or broker’s hazard analysis on faith without an internal qualified-individual review.
- No record showing the relied-upon hazard analysis was ever evaluated for adequacy or currency.
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 1.1× the rate of the average FDA-cited firm (8.8% vs 7.8%), across 274 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 did not document your review and assessment of a hazard analysis conducted by another entity.
You did not document your review and assessment of a hazard analysis conducted by another entity.
You did not document that a hazard analysis conducted by another entity was conducted by a qualified individual.
You did not document your review and assessment of a hazard analysis conducted by another entity.
You did not document your review and assessment of a hazard analysis conducted by another entity.
You did not document your review and assessment of a hazard analysis conducted by another entity and that a hazard analysis conducted by another entity was conducted by a qualified individual.
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 →