What is the Foreign Supplier Verification Program (FSVP)?

FSVP is an FDA program that requires U.S. importers to verify that imported food is produced in a manner that provides the same level of public health protection as U.S. standards, and that the food is not adulterated or misbranded with respect to allergen labeling.

Who is responsible for FSVP compliance?

The U.S. importer is generally responsible for FSVP compliance. The responsible importer depends on the import arrangement and may be the owner/consignee or, if none, the U.S. agent/representative of the foreign owner/consignee.

Do I need an FSVP agent?

Many importers use an FSVP agent or consultant to help prepare and maintain FSVP documentation and to support inspection readiness. FDA Registration Assistance can act as an FSVP agent and provide ongoing support.

What does an FSVP plan typically include?

An FSVP plan typically includes supplier approval, hazard analysis considerations, verification activities, corrective action procedures, and records demonstrating that verification steps are performed and maintained.

What happens if I do not have FSVP documentation during an FDA inspection?

Lack of required FSVP documentation can lead to FDA findings, additional scrutiny, or import-related actions. FDA Registration Assistance helps clients prepare documentation and organize records to reduce compliance risk.

Can you help with FSVP for Amazon sellers and small importers?

Yes. We support Amazon sellers and small importers with FSVP plans and compliance documentation tailored to product type, supplier risk, and import profile.

Foreign Supplier Verification Program (FSVP Plan)

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FSVP Plan
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FSVP Agent
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Foreign Supplier Verification Program (FSVP) Compliance Services

In May 2017, the U.S. Food and Drug Administration (FDA) implemented the Foreign Supplier Verification Program (FSVP) under the Food Safety Modernization Act (FSMA). This rule requires U.S. importers of food and beverages to develop and maintain an FSVP plan demonstrating that they are performing proper due diligence to ensure the safety and compliance of imported food products.

The purpose of FSVP is to make importers an active part of the food safety system. By holding importers accountable for supplier oversight, the FDA aims to reduce the amount of violative food and beverage products entering the U.S. market.

The FSVP rule requires importers to conduct risk-based foreign supplier verification activities to confirm that imported food meets U.S. safety standards.

Under FSVP, importers must verify that:

Food is produced using processes that provide the same level of public health protection as required under:
- Section 418 of the FD&C Act (Hazard Analysis and Risk-Based Preventive Controls), or
- Section 419 of the FD&C Act (Standards for the Safe Growing, Harvesting, Packing, and Holding of Produce), where applicable
  (21 U.S.C. §§ 350g and 350h)
Food is not adulterated under Section 402 of the FD&C Act
(21 U.S.C. § 342)
Human food is not misbranded, including proper allergen labeling requirements under Section 403(w) of the FD&C Act
(21 U.S.C. § 343(w))

FSVP Plan Creation & Maintenance Services

FDA Registration Assistance has a proven, structured process for creating FSVP plans that meet FDA inspection standards.

We can deliver a fully compliant FSVP plan in as little as 5 business days.

Our services include:

Full FSVP plan development
Hazard analysis and supplier evaluation
Verification activity documentation
Ongoing FSVP maintenance and updates
Acting as your FSVP Agent when required

Once your plan is created, you may choose to:

Maintain the FSVP plan internally, or
Have FDA Registration Assistance manage and maintain the plan on your behalf

Why FSVP Compliance Is Critical

Failure to maintain a compliant FSVP plan may result in:

FDA Form 483 observations
Import alerts and shipment refusals
Detention without physical examination (DWPE)
Civil or regulatory enforcement action

Having a properly documented and maintained FSVP plan helps ensure your business remains compliant and inspection-ready.

If you would like to learn more about FSVP requirements or need assistance creating or maintaining an FSVP plan, please contact us today.

Frequently Asked Questions (FAQ)

What is an FSVP plan?

An FSVP plan is a written document required by the FDA that demonstrates how an importer verifies that their foreign suppliers produce food that meets U.S. safety and labeling standards.

Who is required to have an FSVP plan?

Any U.S. importer of record bringing food or beverages into the United States must have an FSVP plan, unless a specific exemption applies.

Is an FSVP plan required for every product?

Yes. FSVP requirements apply per supplier and per product, based on risk and hazard analysis.

How quickly can an FSVP plan be created?

FDA Registration Assistance can typically prepare a compliant FSVP plan within 5 business days, depending on product complexity and supplier documentation.