Project-based service

FSVP Importer Agent

When U.S.-bound food enters without a U.S. owner or consignee, a U.S.-based FSVP agent must be designated to carry the foreign supplier verification responsibility. We act as your FSVP importer agent and coordinate the fulfilment and recordkeeping of the verification obligations.

RegulatorU.S. FDA

Applies whenNo U.S. owner or consignee at entry

Designation~1-2 weeks

RoleRegulatory responsibility at import

On this page

What this service is

Under 21 CFR Part 1, Subpart L, the FSVP importer is the U.S. owner or consignee of the food at entry. When no such party exists, a U.S. agent or representative must be designated to carry the FSVP responsibility, and that party's identity information must be provided in the entry filing.

An FSVP agent is not the same as the U.S. agent used in food facility registration: the FSVP agent carries a regulatory responsibility for foreign supplier verification at import, while the registration U.S. agent is only a point of contact between the facility and FDA. The two roles can be appointed separately.

FSMA (2011)FD&C Act §80521 CFR Part 1 Subpart L

Who needs it

Food exporters selling directly to U.S. end customers with no U.S. importer in the chain

Businesses importing under DDP-style terms that need an FSVP-responsible party

Companies selling food into the U.S. through cross-border direct-shipping or e-commerce models

Prerequisites and sequence

FDA Food Facility Registration→FSVP Importer Agent

The foreign supplier for each U.S.-bound product is identified and willing to cooperate with a baseline evaluation
The manufacturing facility has completed FDA food facility registration
The exporter is willing to cooperate with hazard analysis and recordkeeping as the FSVP rule requires

Who holds regulatory responsibility

Acting as FSVP agent means carrying the regulatory responsibility for supplier verification of the imported food in FDA's records. The agent agreement defines the boundaries of that role: the exporter must ensure that product and supplier information provided is authentic and must cooperate with verification activities and corrective actions.

Materials we need from you

Basic details of the exporter and the manufacturing facility

List of U.S.-bound products with formulation and process descriptions

Supplier food safety system documentation

Expected shipping plan and port-of-entry information

Process

01
Sign the FSVP agent agreement
02
Complete an initial scoping and risk assessment of the products
03
Set up or connect the FSVP file (can be combined with the verification report service)
04
Provide the agent identity information required for entry filings
05
Coordinate FDA inquiries and inspections during the service term
06
Annual review and renewal assessment

Deliverables

The FSVP agent agreement and designation confirmation

The FSVP file framework

Agent information documents for entry filings

A record of FDA communications during the service term

Timeline

After the agreement is signed and materials are complete, the agent designation and file framework are typically in place within about 1-2 weeks. Products requiring per-product verification reports follow the project timeline of that service.

Scope

What we provide

FSVP agent designation and entry-filing information support
Coordination of FDA inquiries and inspections
FSVP file framework setup
Obligation reminders and an annual review during the service term

What is not included

Per-product verification report preparation (engaged separately — see the FSVP verification report service)
Actual import customs clearance, duties, and logistics
Any factual guarantee of product quality or safety

What usually follows

FSVP Importer Verification Report

Common pitfalls

Confusing the FSVP agent with the registration U.S. agentThe U.S. agent used in facility registration is only a contact point and carries no FSVP responsibility. If food enters without a U.S. owner and only a registration agent exists, the FSVP-responsible party is missing and the shipment can be refused at the port.

Shipping first, designating the responsible party laterThe FSVP agent's identity information must be provided in the entry filing. Discovering at the port that no responsible party exists means detention and possible re-export — complete the designation before shipment.

Assuming the agent guarantees product qualityThe FSVP agent carries the regulatory responsibility for supplier verification; it does not provide any factual guarantee of product quality or safety. The exporter must still supply authentic information and cooperate with verification activities and corrective actions.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Is the FSVP agent the same as the U.S. agent for facility registration?

No. The registration U.S. agent is a point of contact between the facility and FDA; the FSVP agent carries the regulatory responsibility for foreign supplier verification at import. The roles can be appointed separately or, where appropriate, held by the same party.

When is an FSVP agent mandatory?

When food enters the United States without a U.S. owner or consignee — for example, when the exporter supplies U.S. end customers under DDP terms — a U.S.-based agent must be designated to carry the FSVP responsibility.

Does the agent service include the verification report?

The agent service resolves the responsible-party question. Hazard analysis and verification reports are a separate technical service priced per product, and can be engaged together.

Related services

FSVP Verification ReportBuild your Foreign Supplier Verification Program file under FSMA (21 CFR Part 1, Subpart L) and receive a per-product verification report covering hazard analysis, supplier evaluation, and verification activity records. Priced per product.Food U.S. AgentForeign food facilities must designate a U.S.-based agent when registering with the FDA, serving as the point of contact between FDA and the facility. We provide an annual U.S. agent service covering registration support, renewals, and day-to-day FDA correspondence.Food Facility RegistrationAny facility that manufactures, processes, packs, or holds food for the U.S. market must register with the FDA. We prepare the registration, arrange the U.S. agent appointment, and obtain the registration number; a D-U-N-S Number is required before registration.

Disclaimer

The scope of the FSVP agent role is governed by the signed agent agreement. This page is general information, not legal advice.