FDA 483 OBSERVATION · #38 OF 1,923 MOST-CITED
Approved supplier procedures - importer established
FDA cited this observation 588 times across 545 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 establish and follow written procedures to ensure it imports foods only from foreign suppliers it has approved (or, temporarily and with verification, from unapproved suppliers).
Why FDA writes it — Approving suppliers is the gate that keeps unverified sources out of the supply chain. Without written approved-supplier procedures, food can enter from suppliers whose hazard control was never evaluated — defeating the purpose of the FSVP.
- Establish and follow written procedures to ensure that you import foods only from approved foreign suppliers.
- Base supplier approval on the evaluation of food risk and supplier performance (§1.505).
- Where you temporarily import from an unapproved supplier, do so only under adequate verification before use, and document it.
- Keep records of approved suppliers and the basis for approval.
- No written approved-supplier procedure, so sourcing is not gated by approval.
- Importing from unapproved suppliers without the interim verification the rule allows.
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 1.6× the rate of the average FDA-cited firm (12.7% vs 7.8%), across 545 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 to ensure that you import foods only from approved foreign suppliers.
You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.
You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.
You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.
You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.
You did not establish written procedures to ensure that you import foods only from approved foreign suppliers.
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 →