FDA 483 OBSERVATION · #1 OF 1,923 MOST-CITED
Develop FSVP
FDA cited this observation 4,927 times across 3,615 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 importer of record had not developed a Foreign Supplier Verification Program (FSVP) for the food it brings into the United States. Under FSMA, the importer — not the foreign manufacturer — is the responsible party, and the FSVP is the written program proving the imported food was produced under controls at least equivalent to U.S. preventive-controls or produce-safety rules.
Why FDA writes it — It is the single most-cited FDA observation because FSVP inspections are records reviews of importers, of which there are tens of thousands, and the requirement is a document that either exists or does not. No FSVP means FDA has no assurance the food met a U.S.-equivalent safety standard before it entered commerce.
- Identify who the FSVP importer is for each line — the U.S. owner/consignee at entry, or their U.S. agent when there is no owner/consignee — and put that name and DUNS number on the entry filing.
- For each food from each foreign supplier, conduct a hazard analysis, evaluate the supplier’s performance and the risk the food poses, and choose verification activities (on-site audit, sampling/testing, or records review) proportionate to that risk.
- Document the program in writing, keep it current, and retain records that verification actually occurred — the inspection is a review of those records.
- Reassess the FSVP at least every three years, or sooner when you learn new information about a hazard or the supplier’s performance.
- The importer assumes the foreign supplier’s certifications or a customs broker cover the obligation — but FSVP is a distinct, importer-owned program.
- A small or infrequent importer is unaware the rule applies to them, or has no written program at all despite years of importing.
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 1.4× the rate of the average FDA-cited firm (10.9% vs 7.8%), across 3,615 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 develop an FSVP.
You did not develop an FSVP.
You did not develop an FSVP.
You did not develop an FSVP.
You did not develop an FSVP.
You did not develop an FSVP.
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 →