FDA 483 OBSERVATION · #29 OF 1,923 MOST-CITED
Importer verification
FDA cited this observation 704 times across 526 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 FSVP importer did not conduct — or did not adequately conduct — the foreign-supplier verification activities its own program requires, so the control of hazards by the foreign supplier was not actually verified.
Why FDA writes it — FSVP works only if the importer performs the verification it committed to. Having a program on paper but not carrying out the audits, sampling, or records reviews it specifies means the imported food’s safety was never confirmed — the exact gap FSVP exists to close.
- Perform the supplier-verification activities your FSVP specifies (on-site audit, sampling/testing, or records review) at the frequency your risk determination requires.
- Match the verification activity to the hazard: a hazard with a serious adverse health consequence generally warrants an annual on-site audit unless a documented rationale supports otherwise.
- Document each verification activity and its outcome, and act when it reveals a problem.
- Reassess verification when the hazard, food, or supplier performance changes.
- A written FSVP that is never executed — verification activities scheduled but not performed or recorded.
- Verifying to a generic frequency that does not match the hazard’s severity.
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 (12.0% vs 7.8%), across 526 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 or have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation.
You do not have or have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation.
You do not have or have not implemented an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation.
You do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation.
You do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation.
You do not have or have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation.
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 →