US import compliance
FSVP: what you must hold on every foreign supplier
The Foreign Supplier Verification Program is the importer obligation, not the supplier obligation. But it is built almost entirely from supplier evidence, and an inspection asks to see that evidence rather than a promise of it.
Last reviewed: September 22, 2026
01
Who carries it
The FSVP importer is the US owner or consignee of the food at the time of entry. Where there is no US owner or consignee, it falls to the US agent or representative of the foreign owner. That representative must agree to serve as the FSVP importer in a signed statement.
On each line entry, the FSVP importer name, email address and DUNS number must be provided when filing with CBP (21 CFR 1.509(a)).
The UNK shortcut is gone. Until July 2022 an entity role code of UNK could stand in for the DUNS number. That policy was withdrawn: since July 24, 2022 a recognized DUNS is required at filing. Importers who never updated their broker instructions still trip over this.
02
What the program must contain
An FSVP is not a certificate. It is a maintained file, per food and per supplier.
| Hazard analysis | Identify biological, chemical and physical hazards for each food, judging probability and severity if no control were applied. An analysis done by another party may be relied on, provided it is reviewed. |
|---|---|
| Evaluation | Assess the hazard analysis, who controls each hazard, the supplier procedures, its FDA compliance history and its food-safety record. |
| Verification | Carry out activities appropriate to the hazard - see section 3. |
| Corrective action | Act promptly where a supplier fails to meet the standard, or where food is adulterated or misbranded for allergens. |
| Reevaluation | At least every three years, and sooner whenever new information comes to light. |
03
Choosing verification activities
The rule offers a choice of activity, but not a free one: it must match the hazard.
- On-site audit before initial importation and at least annually thereafter - generally required when a hazard controlled by the foreign supplier could cause serious adverse health consequences or death. An alternative requires a documented determination that it gives adequate assurance of safety.
- Sampling and testing of the food.
- Review of the supplier food-safety records.
The practical consequence: for a serious hazard controlled by the foreign supplier, the importer keeps the audit evidence, or the documented justification and evidence for an appropriate alternative, and must be able to produce it.
04
Exemptions worth knowing
FSVP does not apply uniformly. Several exemptions matter in these categories.
- Low-acid canned foods - for microbiological hazards controlled under 21 CFR Part 113, the importer verifies and documents that the food was produced in compliance with Part 113. Every other hazard remains subject to FSVP. This catches importers out, because the exemption is narrower than it sounds.
- Juice, fish and fishery products subject to, and in compliance with, the applicable FDA HACCP regulations.
- Meat, poultry and egg products regulated by USDA rather than FDA.
- Alcoholic beverages, and food for research, personal consumption or re-export.
- Very small importers, and importers buying from certain small foreign suppliers, have modified requirements rather than none.
A low-acid exemption is not a blanket exemption. A canned product may sit outside FSVP for microbiological hazards and still require a full FSVP for chemical hazards such as heavy metals or process contaminants. The exemption is hazard-specific, because that is how it is written.
05
Where FSVP files fail inspection
- The file names a hazard but holds no evidence that anyone controls it.
- Verification activity does not match the hazard - a records review used where the hazard warranted an audit, with no documented justification.
- The audit or certificate on file has expired, or its scope does not cover the product actually shipped.
- Reevaluation is overdue - the three-year clock is easy to lose across a long supply relationship.
- A DUNS number is missing from entry filing, or belongs to the wrong entity.
- The supplier changed producing site and the file still describes the old one.
06
What we provide
ALPHATRADE coordinates the supplier-side documents agreed for the program. The designated FSVP importer remains responsible for determining whether those documents and its verification activities meet the applicable requirements.
- Producing-site qualification records, with the scope of each audit stated - not only its existence
- Certificate status and validity dates for the producing site under review
- Product specifications and analytical parameters per category, to support the hazard analysis
- Site and process information where a hazard is controlled upstream
- Notification when a producing site or process changes, so reevaluation is triggered rather than discovered by an inspector
Next step
Planning a program that has to meet these requirements?
Send the product, target market, pack format and expected volume. We review the commercial fit and come back with the questions that matter before a quotation.
Source and scope
Source. 21 CFR Part 1 Subpart L, and the FDA published key-requirements summary and guidance for the Foreign Supplier Verification Programs final rule. Provisions are cited inline. FDA: FSVP final rule.
Scope. General information for commercial importers, not legal advice. It does not replace your own FSVP qualified individual, your customs broker, or verification with the FDA. Requirements change; confirm the current position before relying on them.
Inquiries: sales@alphatradecorp.com