FSVP: prove each foreign supplier controls its hazards
If you import food into the US, the duty to verify the foreign supplier is yours. Here is what the rule asks and how to keep the evidence.
In Short
- Evaluate each food and supplier before approval.
- Serious hazards: onsite audit before first import, then annually.
- Reevaluate on new information, at least every 3 years.
The Foreign Supplier Verification Programs rule, 21 CFR Part 1 Subpart L, is binding US law for most food importers. The importer, not the foreign supplier, holds the obligation. This guide covers the sections importers ask about most. Every section cited was checked on the eCFR on 2 Oct 2026.
Who and what
The FSVP importer is generally the US owner or consignee of the food at entry. A qualified individual develops the program and performs FSVP activities (1.503).
More on who and what
Some foods and importers have modified requirements or exemptions.
Hazard Analysis and Supplier Evaluation
1.504 requires a hazard analysis for each food. 1.505 requires evaluating the supplier and food before approval, considering the hazards, who controls them and the supplier's performance.
More on hazard Analysis and Supplier Evaluation
Reevaluate promptly when new information arrives, and at least every 3 years.
Verification Activities
1.506 sets verification activities such as onsite audits, sampling and testing, and records review. Where the supplier controls a hazard that could cause serious adverse health consequences or death, an onsite audit is needed before first import and at least annually, unless a written determination justifies another approach.
Which verification activity?
Pick the hazard situation.
- Before first import and at least annually, unless a written determination justifies another approach (1.506).
Corrective Actions and Entry
1.508 requires corrective actions when a supplier is not meeting requirements, including stopping use where needed. 1.509 requires the importer's name, email and unique facility identifier at entry.
Records and where V5 fits
1.510 requires records to be kept at least 2 years. V5 supports supplier qualification and monitoring, supplier audits, document submission through the supplier portal, CAPA and lot trace.
FSVP records retention (1.510)
| Record | Keep for |
|---|---|
| FSVP records generally | At least 2 years after created or obtained |
| Processes, procedures, evaluations | At least 2 years after their use is discontinued |
- FSVP records generally
- Keep for
- At least 2 years after created or obtained
- Processes, procedures, evaluations
- Keep for
- At least 2 years after their use is discontinued
More on records and where V5 fits
Your qualified individual decides approval and verification.
Questions
Is FSVP law or guidance?
21 CFR Part 1 Subpart L is binding law. FDA also publishes nonbinding guidance on applying it.
How often must foreign suppliers be audited?
Only certain cases require onsite audits: where the supplier controls a hazard that could cause serious adverse health consequences or death, before first import and at least annually, unless a written determination justifies another approach (1.506).
How long are FSVP records kept?
At least 2 years after they were created or obtained; process and procedure records for at least 2 years after their use is discontinued (1.510).
Does V5 approve foreign suppliers?
No. V5 keeps supplier records, audits and documents. Your qualified individual decides approval and verification activities.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
- Australia and NZ Supermarket Supplier Standards Guide
Canada Supermarket Supplier Standards: Readiness Guide
Foreign Material Control and Metal Detection Readiness
France Supermarket Supplier Standards: Readiness Guide
Germany and DACH Supermarket Supplier Standards Guide
Global Supermarket Supplier Standards: the Own-Brand Stack