Foreign Supplier Verification Workflow

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FSVP - Verifying That Imported Food Meets U.S. Safety Requirements

The Foreign Supplier Verification Program rule requires importers of food into the United States to verify that their foreign suppliers produce food in a way that provides the same level of public health protection as U.S. requirements. The importer must use a qualified individual, conduct a written hazard analysis, evaluate and approve each foreign supplier, determine and carry out risk-based verification activities, take corrective action, identify itself at entry, and keep records. This map follows the pathway from importer setup through supplier approval, verification, and reevaluation.

21 CFR Part 1 Subpart L · FSMA Section 301 · FSVP Importer

21 CFR 1 Subpart L

FSMA Section 301

Qualified Individual

FSVP Importer

The U.S. owner or consignee of the food at the time of entry, or the U.S. agent, who is responsible for the FSVP.

Basis: Responsible party

Qualified Individual

A person with the education, training, or experience needed to develop the FSVP and perform its activities.

Basis: 21 CFR 1.503

Supplier Verification

Onsite audits, sampling and testing, review of the supplier's food safety records, and other appropriate activities.

Basis: Risk-based and documented

Importer Identification

Name, email, and an FDA-acceptable unique facility identifier provided to CBP for each entry line.

Basis: 21 CFR 1.509

Phase 1

Importer Setup and Hazard Analysis

1Identify imported foods, suppliers, and your role

Each food and foreign supplier identified, with confirmation that you are the FSVP importer and whether an exemption applies.

21 CFR 1.500 · 1.501 · 1.502

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2Designate qualified individuals

A qualified individual develops the FSVP and performs its activities, and a qualified auditor conducts required audits.

21 CFR 1.503

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3Conduct a written hazard analysis

Known or reasonably foreseeable biological, chemical, and physical hazards identified and evaluated, in writing whatever the result.

21 CFR 1.504

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4Determine who controls each hazard

Whether the foreign supplier, a downstream customer, or a later step controls each hazard that requires a control.

21 CFR 1.504 · 1.507

Phase 2

Supplier Evaluation and Approval

Does the supplier control a hazard with a reasonable probability of serious harm or death?

YES → Onsite audit before first import and annually NO → Choose other risk-based verification

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5Evaluate supplier performance and food risk

Hazards, supplier procedures and compliance history, and the food's risk considered together and documented.

21 CFR 1.505(a)

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6Approve foreign suppliers

Suppliers approved based on the evaluation, with the basis recorded before food is imported.

21 CFR 1.505(b)

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7Determine verification activities and frequency

Audit, testing, records review, or other activities chosen and documented before importing, with a rationale.

21 CFR 1.506(b)

Phase 3

Verification and Corrective Action

8Conduct verification activities

Qualified auditors, sampling and testing, and record review carried out at the set frequency, without conflicts of interest.

21 CFR 1.506(e)

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9Identify the importer at entry

Name, email, and a unique facility identifier provided electronically to CBP for each entry line.

21 CFR 1.509

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10Take corrective action promptly

When a supplier is not producing food as required, act promptly, including discontinuing use, and check whether the FSVP is adequate.

21 CFR 1.508

Phase 4

Records and Reevaluation

11Document the FSVP

Hazard analysis, evaluation, approval, verification, and corrective action records signed and dated by the importer.

21 CFR 1.510(a)

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12Retain and produce records

Records kept at least 2 years, available promptly to FDA, and retrievable within 24 hours if held offsite.

21 CFR 1.510(c)

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13Reevaluate the supplier and the program

Reevaluation when new information arises, and at least every 3 years if none has occurred.

21 CFR 1.505(c)

Verification Activities (Overview)

Onsite Audit

For a serious hazard the foreign supplier controls, an audit is required before first import and at least annually, unless a written determination supports other or less frequent verification.

21 CFR 1.506(d)(2)

Sampling and Testing

Product testing at a frequency tied to the hazard and the supplier's record, with results reviewed and acted on.

21 CFR 1.506(e)

Records Review and Other Activities

Review of the supplier's food safety records and other appropriate activities. The foreign supplier generally cannot perform its own verification, except sampling and testing.

21 CFR 1.506(e)

Supplier Nonconformance Response (Overview)

Detect Audit, testing, or record review shows the supplier is not producing food as required.

Act promptly Corrective action is taken without delay, which may include stopping the use of the supplier or holding shipments.

Check the program If a problem is found by other means, such as an FDA inspection, the importer investigates whether the FSVP is adequate.

Document and modify The action and its basis are recorded, and the FSVP is modified where it proved inadequate.

Key FSVP Outputs (Overview)

Written hazard analysis Hazards for each imported food, identified and evaluated, with the control and who applies it.

Supplier evaluation and approval record The basis for approving each foreign supplier and the verification activities chosen.

Verification records Audit reports, test results, and record reviews supporting the importer's conclusions.

Corrective action and reevaluation records What was done when a supplier fell short, and when each supplier was reevaluated.

FSVP Quality Elements

Qualified Individual People who develop and run the program have documented education, training, or experience.

Written Hazard Analysis A written analysis for every food, whether or not hazards require a control.

Supplier Performance Evaluation A documented look at each supplier's history and procedures, not just a certificate.

Documented Approval Suppliers approved before use, with the reasoning recorded.

Risk-Based Verification Activities and frequency matched to the hazard and the supplier, and explained.

Independent Verification Verification performed by or for the importer, not accepted from the supplier itself.

Corrective Action Readiness A defined response when a supplier fails, including discontinuing use.

Reevaluation and Records Reevaluation on new information and at least every 3 years, with records kept 2 years or more.

Never do this

Rely on the foreign supplier's own audit or verification. Import before deciding how the supplier will be verified. Skip the written hazard analysis because "the hazards are minor". Leave the importer identifier off the entry. Go past the 3-year point without reevaluating.

FSVP vs supply-chain program

FSVP applies to importers bringing food into the United States. The supply-chain program applies to a receiving facility under Part 117. Certain receiving facilities have modified FSVP requirements under 21 CFR 1.502, so an importer that is also a facility should check how the two programs interact.

Exemptions and modified requirements

Exemptions include juice and seafood where the supplier complies with Parts 120 or 123, food for research or evaluation, personal consumption, and USDA-regulated meat, poultry, and egg products. Dietary supplements and very small importers have modified requirements.

Key regulations

21 CFR Part 1 Subpart L, 1.500 to 1.514. FSMA Section 301. 21 CFR 1.503 - qualified individuals. 21 CFR 1.504 to 1.508 - hazard analysis, evaluation, verification, and corrective action. 21 CFR 1.509 - importer identification. 21 CFR 1.510 - records.