INTERNATIONAL TRADE LAW
FSVP Compliance: Surviving an FDA Importer Audit
An FSVP audit is the FDA’s check that you, the U.S. importer, have a written Foreign Supplier Verification Program proving each foreign supplier produces food that meets U.S. safety standards. The inspector reviews your program and records — not your supplier’s factory — so passing comes down to whether your paperwork is complete, current, and on hand. This guide explains what FSVP requires and how to be ready.
A note on the name: the program is the Foreign Supplier Verification Program (FSVP), established by the FDA’s FSVP rule at 21 CFR Part 1, Subpart L. Older write-ups sometimes call it a “Food Safety Verification Program” — that label is incorrect, and using it in your own records signals to an inspector that the program may not be well understood.
Who Is the FSVP Importer
The FSVP importer is the U.S. owner or consignee of the food at the time of U.S. entry. If there is no U.S. owner or consignee at entry, it is the U.S. agent or representative of the foreign owner, named in writing. There is exactly one FSVP importer per line of food per entry, and that party carries the legal obligation. Identifying the wrong party — or assuming the broker handles it — is a common and costly mistake.
What Your FSVP Must Contain
For each food from each foreign supplier, the program must document:
| Element | What it means |
|---|---|
| Hazard analysis | Identify known or reasonably foreseeable hazards (biological, chemical, physical) for the food |
| Supplier evaluation | Assess the supplier’s performance and the risk the food presents |
| Verification activities | Choose and perform checks — on-site audits, sampling and testing, or records review — matched to the risk |
| Corrective actions | Document how you respond when a supplier falls short |
| Records | Keep everything, available to the FDA promptly on request |
Where a hazard requires control before import, the rule generally calls for an annual on-site audit of the supplier unless the risk justifies a lighter activity.
What an FSVP Inspection Looks Like
FSVP inspections are usually records-based and often remote. An FDA investigator contacts the importer, requests the FSVP records for specific products, and reviews them — frequently by email or video, not a factory walk-through. You must be able to produce the records promptly, and provide an English translation within a reasonable time for anything kept in another language.
Common findings: no FSVP at all for a product, a missing or stale hazard analysis, supplier verification that doesn’t match the hazard, or records that exist but can’t be located quickly. Each is avoidable with maintenance.
How to Prepare
- Inventory every food and supplier. Confirm there is a current FSVP for each food-supplier pair you import.
- Refresh the hazard analysis. Re-evaluate when the food, supplier, or process changes — at least review it periodically.
- Match verification to risk. Keep the audit reports, lab results, or records reviews that justify your chosen activity.
- Centralize records. Store the program where you can retrieve any document within a day, with translations ready.
- Confirm the DUNS number. Since July 24, 2022, the FSVP importer’s unique facility identifier (DUNS) must be transmitted at entry.
Modified Requirements for Very Small Importers
The rule eases the burden for very small importers (and for food from certain small suppliers): instead of a full hazard analysis and verification regime, they can rely on documentation that the supplier is in compliance, plus written assurances. You still need records, and you must meet the size definition to qualify — so confirm eligibility before relying on the modified path.
Frequently Asked Questions
What triggers an FSVP audit?
The FDA selects importers for FSVP inspection on a risk and routine basis; there is no warning requirement. Because inspections are records-based, readiness is about maintaining the program continuously, not preparing once a notice arrives.
Is an FSVP audit the same as a factory inspection?
No. An FSVP inspection reviews the importer’s written program and records, usually remotely. A supplier audit — verifying the foreign facility itself — may be one of the verification activities inside your FSVP, but the FSVP inspection targets your documentation.
Who has to have an FSVP?
The U.S. importer of FDA-regulated food, defined as the U.S. owner or consignee at entry (or a designated U.S. agent if there is none). The obligation cannot be shifted to the customs broker.
Can I reduce FSVP requirements if I’m small?
Possibly. Very small importers and importers of food from certain small suppliers qualify for modified requirements, but only if they meet the rule’s size definitions and keep the required documentation.
A clean FSVP is built before the inspector calls, not during the email exchange. Reidel Law Firm helps importers build and maintain FSVP programs that hold up to FDA review, on flat-fee terms. Get an import compliance memo.
