A Foreign Supplier Verification Program (FSVP) plan is a written document required by the FDA that demonstrates how a U.S. importer verifies that their foreign suppliers produce food that meets U.S. safety and labeling standards. It must include a hazard analysis, supplier risk evaluation, and documented verification activities.

An FSVP importer generally is the U.S. owner or consignee of food offered for import into the United States. If there is no U.S. owner or consignee at the time of entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee, as confirmed in a signed statement of consent. FSVP applies unless an exemption or modified requirement applies.

FSVP requirements must be addressed for each imported food and each applicable foreign supplier. Documentation can be organized within a managed FSVP system, but the hazard analysis, supplier evaluation, and verification decisions must cover the specific food and supplier relationship. FDA Registration Assistance can manage plans for multiple products and suppliers.

FDA Registration Assistance can typically prepare a compliant FSVP plan within 7–10 business days, depending on product complexity and supplier documentation. We will confirm your timeline during the intake process.

Failure to maintain a compliant Foreign Supplier Verification Program (FSVP) plan can result in FDA Form 483 observations, import alerts, shipment detention or refusal (DWPE), and civil or regulatory enforcement action. Having a properly documented FSVP ensures your products can enter the U.S. without disruption.

FSVP compliance pricing is custom based on your specific needs — including the number of products, suppliers, and level of ongoing support required. We also offer U.S. Agent services as part of our FSVP program. Contact FDA Registration Assistance for a custom quote tailored to your business.

Yes. “FSVP Agent” is commonly used as a service description, but FDA legally defines the responsible role as the FSVP importer. FDA Registration Assistance can manage FSVP documentation and verification support and can discuss serving as the U.S. agent or representative FSVP importer where the regulation permits. The applicable legal structure depends on who owns or has purchased the food at the time of entry.

FDA Registration Assistance will guide you through all required information during our intake process. Typically this includes your company details, product descriptions, foreign supplier names and locations, and any existing food safety documentation.

FSVP plans must be reviewed and updated at least every three years, or sooner when there are changes in suppliers, processes, or hazard information. FDA Registration Assistance manages your FSVP maintenance every year so you are always compliant and never caught off guard during an inspection.

FSVP is established under Section 301 of the Food Safety Modernization Act (FSMA) and codified at 21 CFR Part 1, Subpart L. The rule went into effect on January 26, 2016, with compliance dates beginning in May 2017.

Yes. Certain categories are exempt or have modified requirements, including juice and fish products subject to HACCP regulations, food for research or personal consumption, alcoholic beverages, and food from countries with an equivalent food safety system. Contact FDA Registration Assistance for a compliance review if you believe an exemption may apply.

FSVP importers must provide a Unique Facility Identifier (UFI) — specifically a DUNS number — for each line entry of food offered for importation. The FDA recognizes the DUNS number (issued by Dun & Bradstreet) as the acceptable UFI. FDA Registration Assistance can assist with DUNS number requests as part of our FSVP services.

Verification activities may include onsite audits, sampling and testing, review of the supplier’s relevant food safety records, or other appropriate activities. When a hazard controlled by the foreign supplier is a SAHCODHA hazard, an onsite audit before initial importation and at least annually thereafter is generally required unless the importer makes and documents an adequate written determination that other activities and/or less frequent auditing provide adequate assurance. FDA Registration Assistance helps determine the appropriate activities for your specific supplier and product risk profile.

Yes, with some variations. Importers of dietary supplement ingredients who verify compliance with CGMP specifications may be exempt from most standard FSVP requirements. Importers of finished dietary supplement products must comply with most FSVP requirements, with verification activities focused on CGMP compliance.

A hazard analysis identifies and evaluates known or reasonably foreseeable biological, chemical, and physical hazards associated with the imported food. It assesses the probability and severity of harm if controls are not in place. FDA Registration Assistance conducts a thorough hazard analysis as part of every FSVP plan we develop.

Yes. FDA Registration Assistance can provide managed FSVP support from initial plan development and hazard analysis through supplier verification documentation, corrective-action support, ongoing maintenance, and required reanalysis. Where the regulatory conditions are met, we can also discuss U.S. agent or representative FSVP importer support. Contact us for a scope tailored to your import structure.

FDA Registration Assistance provides Foreign Supplier Verification Program (FSVP) services at custom pricing because each importer’s circumstances are different. Pricing can depend on the number and type of imported foods, foreign suppliers, hazard profile, verification activities, shipment scope, records already available, and the level of ongoing support required. Your proposal will clearly identify what is included. Many importers also need Foreign Food Facility Registration for their foreign supplier. Contact us for a tailored quote based on your actual import structure.

A qualifying U.S. person or entity can serve as the FSVP importer when the conditions in 21 CFR 1.500 are met. If there is no U.S. owner or consignee, a U.S. agent or representative of the foreign owner or consignee can serve as the FSVP importer when confirmed in a signed statement of consent. The role carries substantive compliance duties, so using a friend or unrelated party who is not prepared to manage hazard analysis, supplier evaluation, verification activities, records, and FDA inquiries can create significant risk. Professional managed FSVP support helps keep the required documentation organized and inspection-ready.

If the party serving as the FSVP importer does not respond to FDA or cannot provide the required FSVP records, FDA may determine that the importer is not in compliance with the rule. That can lead to enforcement action, including refusal of admission and potential Detention Without Physical Examination (DWPE). Required FSVP records must be made available promptly to FDA upon request, and requested English translations must be provided within a reasonable time. The FSVP importer remains responsible for compliance. FDA Registration Assistance provides responsive managed support during U.S. business hours and helps organize FDA records responses.

To change your Foreign Supplier Verification Program (FSVP) Agent on an existing registration, you must update the FSVP importer information in your written FSVP records and ensure the new agent's name, address, email, and DUNS number are transmitted on every subsequent line entry through CBP's ACE system at the time of import. There is no separate FDA filing form for FSVP — the change takes effect at the next entry filing. FDA Registration Assistance handles the entire transition: we coordinate with your customs broker, update all required entry data, sign the FSVP as the new Qualified Individual, and ensure there is no gap in coverage that could trigger an FDA hold message.

FSVP has exemptions for food imported for research or evaluation and for food imported for personal consumption, but each exemption depends on meeting the conditions in 21 CFR 1.501. A trade-show or sample shipment is not automatically exempt simply because it is small or not sold. The intended use, quantity, labeling, distribution, and entry documentation should be reviewed before relying on an exemption.

Yes, if you meet FDA’s definition of the FSVP importer for the imported food and no exemption applies. Selling through Amazon FBA, Shopify, eBay, Walmart Marketplace, or another e-commerce platform does not remove FSVP obligations. Our FSVP for Amazon Sellers service is designed for businesses importing food for e-commerce sale.

No for cosmetics — the Foreign Supplier Verification Program (FSVP) applies only to food. However, dietary supplements are regulated as food under FSMA and do require FSVP coverage with modified verification activities focused on CGMP compliance under 21 CFR Part 111. Cosmetics fall under MoCRA (Modernization of Cosmetics Regulation Act), a separate framework. Animal feed, pet food, and infant formula are food and therefore covered by FSVP.

FSVP documentation must address each imported food and the applicable foreign supplier. Multiple products from the same supplier can be organized within one managed FSVP system, but the required hazard analysis, supplier evaluation, and verification decisions must adequately cover each food and supplier relationship. FDA Registration Assistance organizes multi-product, multi-supplier programs so the required documentation remains clear and inspection-ready.

The Foreign Supplier Verification Program (FSVP) is a U.S. importer responsibility — it verifies that the foreign supplier produces safe food. Foreign Food Facility Registration is a foreign manufacturer responsibility under 21 CFR Part 1, Subpart H — it lists the facility with the FDA and is renewed every two years. Importers usually need FSVP; their foreign suppliers usually need Foreign Food Facility Registration. Many businesses need both registrations active at the same time to legally ship food into the United States.

No. The Foreign Supplier Verification Program (FSVP) importer must be the U.S. owner or consignee of the food at the time of entry or, when there is no U.S. owner or consignee, the U.S. agent or representative of the foreign owner or consignee as confirmed in a signed statement of consent under 21 CFR 1.500. A foreign entity by itself cannot be the FSVP importer. FDA Registration Assistance can discuss U.S. agent or representative options when this structure applies.

The FDA verifies Foreign Supplier Verification Program (FSVP) compliance in three ways: (1) scheduled and unannounced FSVP inspections at the importer's U.S. business address, where inspectors review hazard analyses, supplier records, and verification activities in person; (2) electronic records requests under Section 414 of the FD&C Act, requiring the FSVP importer to make required records available promptly and, when requested, provide English translations within a reasonable time; and (3) review of the FSVP importer's DUNS number and contact information transmitted on each line entry through CBP's ACE system. Missing or invalid data on any of these channels can trigger an FDA hold.

If a U.S. brand owner is the U.S. owner or consignee of the food at the time of entry, it generally is the FSVP importer and must ensure the applicable FSVP requirements are met for the foreign manufacturer and imported food. A private-label or co-manufacturing agreement does not by itself eliminate FSVP obligations. The hazard analysis and verification activities should reflect the actual imported food and the foreign supplier involved.

The Foreign Supplier Verification Program (FSVP) importer must have a physical U.S. address — not a P.O. box — plus a U.S. phone number and email address that the FDA can use to schedule an inspection or request records. A virtual office or commercial mail receiving address is acceptable only if a responsible person can be reached at that address during U.S. business hours and required FSVP records can be produced promptly in response to an FDA request.

Repeated FSVP violations can lead to FDA Form 483 observations, Warning Letters, refusal of admission, or placement on an Import Alert such as IA 99-41. When an importer and food are subject to DWPE, affected entries may be detained without physical examination until the applicable FDA requirements are satisfied. FDA Registration Assistance can assist with FSVP remediation and, where appropriate, our Import Alert Assistance service.