FDA 483 OBSERVATION · #44 OF 1,923 MOST-CITED
Verification activity before import, periodically
FDA cited this observation 535 times across 484 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 supplier-verification activities before importing and periodically thereafter, so the timing of verification did not meet the program’s requirements.
Why FDA writes it — Verification has to happen at the right time to be meaningful — before reliance on the supplier and then on an ongoing basis. Verification that never occurs, or lapses after the first shipment, leaves later imports unverified.
- Determine and conduct appropriate verification activities before importing the food and periodically thereafter.
- Set the frequency from the risk evaluation, tightening it for higher-severity hazards.
- Document the timing and outcome of each verification activity.
- Trigger additional verification when performance or hazard information changes.
- Verification performed once at onboarding and never repeated periodically.
- No defined periodicity tied to the hazard’s risk.
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 2.3× the rate of the average FDA-cited firm (18.0% vs 7.8%), across 484 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 conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States.
You did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States.
You did not conduct and document or obtain documentation of one or more supplier verification activities periodically after importing the food into the United States.
You did not conduct and document or obtain documentation of one or more supplier verification activities.
You did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States.
You did not conduct and document or obtain documentation of one or more supplier verification activities before importing the food into the United States.
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 →