FDA 483 OBSERVATION · #34 OF 1,923 MOST-CITED
Supplier verification - establish written procedures
FDA cited this observation 624 times across 565 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 firm did not establish written procedures for supplier verification — the supply-chain-program (or FSVP) requirement to ensure that raw materials and ingredients whose hazards are controlled by the supplier are actually verified.
Why FDA writes it — When a hazard in an ingredient is controlled by the supplier rather than the receiving facility, the receiving facility must verify that control. Without written supplier-verification procedures, that control is assumed rather than assured — which is a gap in the preventive-controls (or FSVP) system.
- Establish and follow written procedures for receiving raw materials and ingredients, and for supplier verification activities where a hazard is controlled by the supplier.
- Determine and conduct appropriate supplier-verification activities (on-site audit, sampling/testing, or records review) proportionate to the risk.
- Approve suppliers and document the basis, and keep records of verification activities.
- Reassess when the hazard, supplier performance, or risk changes.
- Supplier control of a hazard assumed on the basis of a certificate, with no written verification program behind it.
- No documented rationale linking the verification activity to the risk the ingredient poses.
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 1.9× the rate of the average FDA-cited firm (14.3% vs 7.8%), across 565 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 establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
You did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
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 →