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FSVP & Foreign Supplier Verification

FSVP Compliance & Foreign Supplier Verification Services

Helping U.S. food importers meet FDA FSVP requirements and foreign manufacturers prepare the documentation their U.S. buyers need.

Request FSVP Assistance Check Your FSVP Requirements

What Is FSVP?

Under the FDA Food Safety Modernization Act, importers must have a Foreign Supplier Verification Program for each food they import and each foreign supplier of that food, unless an exemption applies. The program must provide adequate assurances that the supplier produces the food with at least the same level of public health protection as U.S. requirements.

  • Hazard analysis

    Identify and evaluate known or reasonably foreseeable hazards for each type of food (21 CFR 1.504).

  • Supplier evaluation and approval

    Evaluate the food’s risk and the supplier’s performance, approve suppliers, and reevaluate when new information arises or at least every 3 years (21 CFR 1.505).

  • Supplier verification

    Choose and document verification activities such as onsite audits, sampling and testing, or review of the supplier’s food safety records (21 CFR 1.506).

  • Corrective actions

    Act promptly when a supplier does not meet the required standards, and investigate whether the FSVP is adequate (21 CFR 1.508).

  • Importer identification at entry

    Provide the importer’s name, e-mail and an FDA-recognized unique facility identifier for each line entry (21 CFR 1.509).

  • Records

    Keep signed and dated records, make them available to FDA promptly on request, and generally retain them for at least 2 years (21 CFR 1.510).

Who is who

  • FSVP importer

    The U.S. owner or consignee of the food when it is offered for entry. If there is none, the U.S. agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent (21 CFR 1.500). The FSVP importer is responsible for the FSVP.

  • Foreign food manufacturer

    The facility that makes or processes the food. It has its own FDA obligations, such as facility registration, but it does not hold the importer’s FSVP.

  • Foreign supplier

    For FSVP, the establishment that manufactures or processes the food, raises the animal or grows the food that is exported without further processing by another establishment (adding labels does not count). The importer approves and verifies it (21 CFR 1.500).

  • FDA U.S. agent

    The person a foreign food facility names in its FDA food facility registration as the communication link with FDA. Being a U.S. agent for registration does not make someone the FSVP importer.

  • Qualified individual

    A person with the education, training or experience needed for an FSVP activity, who can read the records involved. Not necessarily an employee of the importer (21 CFR 1.500, 1.503).

  • Third-party certification body

    An organization that audits and certifies facilities against a scheme such as BRCGS, IFS or FSSC 22000. A certificate can support supplier verification, but it is not an FSVP and does not replace one.

Who Needs FSVP Assistance?

FSVP obligations sit with the U.S. importer, but they affect everyone in the supply chain.

U.S. food importers

If you are the U.S. owner or consignee of food when it is offered for entry, you are generally the FSVP importer and need an FSVP for each food and foreign supplier, unless an exemption or modified requirement applies.

Importer services

Foreign manufacturers & exporters

Your U.S. buyers must approve and verify you as a supplier. They will ask for food safety plans, audit reports, certificates, test results and product information.

Manufacturer services

Not every imported food is covered in the same way. 21 CFR 1.501 lists exemptions (for example certain juice and seafood under HACCP rules, food for research or personal consumption, certain alcoholic beverages, transshipped food, U.S. food returned, and certain USDA-regulated meat, poultry and egg products), and other sections set modified requirements, for example for dietary supplements, very small importers, certain small foreign suppliers and low-acid canned foods. We help you work out which rules apply to your facts.

For U.S. food importers

FSVP Compliance Support for U.S. Importers

We help your team build, run and document an FSVP that fits your foods and suppliers. You remain the FSVP importer and make the determinations.

Get Importer Compliance Support
  • FSVP applicability assessment
  • Foreign supplier risk evaluation
  • Food hazard analysis review
  • Supplier verification planning
  • Supplier documentation review
  • Corrective action planning
  • FSVP recordkeeping support
  • Annual compliance review
  • FDA inspection readiness
  • Qualified individual support, subject to verified availability

For foreign manufacturers & exporters

FSVP Readiness for Foreign Food Manufacturers

We help you prepare the documents and information U.S. importers ask for when they approve and verify suppliers.

Readiness assistance for a manufacturer does not replace the U.S. importer’s FSVP obligations. Your importer must still perform and document its own evaluation and verification.

Prepare Your Company for U.S. Buyers
  • Supplier documentation readiness
  • Food safety documentation review
  • HACCP and preventive controls documentation support
  • Product and facility information preparation
  • Supplier questionnaire preparation
  • Certificate and audit report review
  • Corrective action documentation
  • U.S. buyer compliance documentation support

Our Advisory Process

  1. Intake

    Answer the questionnaire below. It takes a few minutes and asks for no confidential documents.

  2. Scoping call

    We confirm your role, products and suppliers, and agree in writing what we will and will not do, and the fee.

  3. Review and plan

    We review the relevant documents through a secure channel we agree with you, and give you written findings and next steps.

  4. Implementation support

    We support your team while you put the plan into practice. Decisions and regulatory responsibility stay with the FSVP importer.

Service Packages

Each engagement is scoped in writing before work starts.

  • Importers & manufacturers

    FSVP Applicability Assessment

    We review your role, products and supply chain against 21 CFR 1.501 and 1.502 and explain whether FSVP is likely to apply, which exemptions or modified requirements may be relevant, and who would be the FSVP importer.

    Advisory fee Request a quote

  • Importers & manufacturers

    Foreign Supplier Document Review

    A structured review of supplier documents such as HACCP or food safety plans, certificates, audit reports and specifications, with a written list of gaps to close.

    Advisory fee Request a quote

  • U.S. importers

    Supplier Risk Assessment

    Support for the hazard analysis and the evaluation of a foreign supplier’s performance and the risk posed by the food, as the basis for choosing verification activities.

    Advisory fee Request a quote

  • U.S. importers

    FSVP Program Development

    We help you draft written FSVP procedures, supplier approval and verification plans, corrective action steps and record templates for your foods and suppliers.

    Advisory fee Request a quote

  • U.S. importers

    Annual FSVP Compliance Review

    A yearly review of your FSVP records, supplier reevaluations and verification results, with findings and recommended corrective actions.

    Advisory fee Request a quote

  • U.S. importers

    FDA Inspection Readiness

    A mock records review and a checklist so your FSVP records can be made available promptly when FDA asks for them.

    Advisory fee Request a quote

  • U.S. importers

    Qualified Individual Support

    Subject to verified availability and a separate written agreement. A qualified individual must have the education, training or experience required for each assigned activity; we confirm qualifications case by case.

    Advisory fee Request a quote

Advisory fees only. Government fees, laboratory testing, audits by third parties, certification bodies, translation and travel are not included. We confirm the scope and fee in writing before any work starts.

FSVP Eligibility Questionnaire

Six short questions help us understand your situation. You will see a preliminary, informational suggestion before you send anything.

Please do not send confidential records here. This public form does not accept food safety records, audit reports, identification documents or attachments. If documents are needed, we agree a secure channel with you first.

1. What best describes your business?
2. What type of food products do you handle?

Select all that apply.

4. Are your products currently being imported into the United States?
5. Do you currently maintain food safety documentation?

Select all that apply. “None” and “Not Sure” cannot be combined with other answers.

6. What assistance do you need?

Select all that apply.

Your contact details

No confidential details, please. Up to 900 characters.

We use your details only to answer this request. Your questionnaire answers are stored with your request and used only to answer it. Sending this request does not sign you up for marketing e-mails. Read the privacy notice

Frequently Asked Questions

The Foreign Supplier Verification Program rule (21 CFR Part 1, Subpart L) is part of the FDA Food Safety Modernization Act. It requires importers to develop, maintain and follow a program that provides adequate assurances that their foreign suppliers produce food with at least the same level of public health protection as U.S. requirements.

No. FSVP is a program the importer runs and documents. FDA does not issue FSVP certificates, and neither does TG Gourmet.

The FSVP importer: the U.S. owner or consignee of the food at the time of entry or, if there is none, a U.S. agent or representative who has signed a statement of consent to serve as the importer. Advisers and suppliers can help, but the importer keeps this responsibility.

No such certificate exists. U.S. importers will, however, ask their foreign suppliers for documents and information they need for their own FSVP, such as food safety plans, audit reports and test results. We help manufacturers prepare those documents.

No. Food facility registration is a separate FDA requirement for facilities that manufacture, process, pack or hold food for U.S. consumption. Registration does not meet FSVP obligations, and an FSVP does not replace registration.

No. The U.S. agent named in a facility registration is a communication link with FDA. A U.S. agent or representative becomes the FSVP importer only when there is no U.S. owner or consignee and it has signed a statement of consent to serve as the importer. That is a separate role with its own responsibilities.

A person with the education, training or experience (or a combination) needed to perform an FSVP activity, who can read and understand the records involved. A qualified individual must develop the FSVP and perform its activities. They do not have to be an employee of the importer.

We can help foreign manufacturers organize, review and complete the documents their U.S. buyers request. We do not certify facilities, and the importer must make its own determinations. Under 21 CFR 1.506, an importer may not rely on the foreign supplier, or the supplier’s employees, to perform supplier verification activities other than sampling and testing, and verification must be free of financial conflicts of interest. So we check for conflicts before we take on verification work for an importer.

It depends on the number of foods and suppliers, the hazards involved and how complete the existing documents are. We give you an estimate after the scoping call and do not promise a fixed timeline.

No. 21 CFR 1.501 lists exemptions, for example certain juice and seafood covered by HACCP rules, food for research or evaluation, food for personal consumption, certain alcoholic beverages, food transshipped or imported for processing and export, U.S. food returned, and certain meat, poultry and egg products regulated by USDA. Modified requirements apply in other cases, for example to some dietary supplements, very small importers, certain small foreign suppliers and low-acid canned foods. Whether an exemption applies depends on the specific facts.

Regulatory Disclaimer

TG Gourmet Advisory provides consulting services. It is not affiliated with, endorsed by or acting for the U.S. Food and Drug Administration, and it is not a certification body or an accreditation body.

FSVP is an importer compliance program, not a certificate. The FSVP importer remains responsible for its FSVP and for its regulatory determinations. An advisory engagement, including a completed one, is not proof that an importer or supplier complies with FDA requirements.

TG Gourmet does not act as your FSVP importer, qualified individual or qualified auditor unless this is agreed separately in writing, after qualifications have been verified and the engagement has been approved internally.

Information on this page is general and may not reflect the latest FDA guidance. It is not legal advice. Exemptions and modified requirements depend on your specific facts.

Regulatory references

Request FSVP Assistance

Tell us about your role, products and suppliers. We reply by e-mail, usually with a few questions and a proposed scope.

Start the questionnaire