FDA 483 OBSERVATION · #25 OF 1,923 MOST-CITED
Evaluation - performance, risk
FDA cited this observation 790 times across 717 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 adequately evaluate the risk posed by a food and the foreign supplier’s performance — the analysis that sets how the supplier is approved and how intensively it must be verified.
Why FDA writes it — The evaluation of food risk and supplier performance is what makes an FSVP risk-based rather than one-size-fits-all. Skipping or weakening it means verification is not calibrated to the actual hazard, so a high-risk supplier may be verified as lightly as a low-risk one.
- Evaluate the risk posed by the food, using the hazard analysis, and the foreign supplier’s performance in controlling that hazard.
- Consider the supplier’s procedures, processes, and practices, applicable FDA compliance history, and the food’s and supplier’s relevant history.
- Use the evaluation to approve suppliers and to determine appropriate verification activities and frequency.
- Reevaluate when new information about the hazard or supplier performance arises.
- Approving a supplier without a documented evaluation of the food’s risk and the supplier’s performance.
- An evaluation that never feeds the choice of verification activity, so risk and effort are disconnected.
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 1.7× the rate of the average FDA-cited firm (12.8% vs 7.8%), across 717 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 that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance.
You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
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 →