Foreign Food Facility FDA Registration
All foreign food facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA. We handle every step — accurately and fast.
Foreign Food Facility Registration is the mandatory FDA filing through which any non-U.S. facility that manufactures, processes, packs, or holds food intended for human or animal consumption in the United States submits its identifying information to the U.S. Food and Drug Administration. The requirement is established by Section 415 of the Federal Food, Drug, and Cosmetic Act and operationalized under 21 CFR Part 1, Subpart H (§§ 1.225 – 1.243), with biennial renewal mandated by the FDA Food Safety Modernization Act (FSMA).
Registration gives the FDA a verified location, contact, and U.S. Agent for every facility shipping food to American consumers, enabling rapid traceback during outbreaks and authorizing lawful entry of shipments at U.S. ports. Without an active registration and a confirmed U.S. Agent, the FDA will refuse entry of shipments at the border, suspend or cancel the registration, and may place the facility on a Detention Without Physical Examination (DWPE) import alert.
What Is Foreign Food Facility Registration?
FDA food facility registration is a mandatory requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Food Safety Modernization Act (FSMA).
All foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA. Registration provides the FDA with critical facility location information and enables emergency response capabilities.
- Mandatory for all foreign food facilities selling into the U.S.
- Must be renewed annually to maintain active registration
- Registration confirmation number issued immediately upon approval
- Enables FDA emergency response and supply chain monitoring
- Non-compliance results in shipment refusals at the U.S. border
- A U.S. Agent must be designated — mandatory for all foreign registrants
* 24–48 hour processing applies only to facilities with a valid DUNS Number (UFI) on file.
Understanding FDA Food Import Regulations
Requirements established under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Food Safety Modernization Act (FSMA).
1. Food Facility Registration
All foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA.
- Mandatory for all foreign food facilities
- Must be renewed annually to stay compliant
- Provides FDA with facility location information
- Enables FDA emergency response capabilities
- Registration confirmation number issued immediately
2. U.S. Agent Designation
All foreign food facilities registering with the FDA are required by law to designate a U.S. Agent who is physically located in the United States.
- Mandatory for every foreign food facility registration
- Must be a U.S. resident or business available 24/7
- Acts as FDA's official point of contact for the facility
- Receives and relays inspection notices and FDA communications
- We provide dedicated U.S. Agent services included with registration
Current Data on Food Facility Registrations
Current data on food facility registrations in the United States
Registrations
Registrations
Comprehensive FDA Compliance Solutions
Tailored to your needs — from first-time registration to ongoing compliance management.
Foreign Food Facility Registration
Complete FDA food facility registration for foreign facilities. We handle every step from document preparation to official FDA submission.
Domestic Food Facility Registration
FDA food facility registration for U.S.-based facilities. We manage the full registration process so your domestic facility stays fully compliant.
U.S. Agent Services
Designated U.S. Agent services for foreign facilities. We act as your official liaison with the FDA, handling all communications and emergency contacts.
FSVP Compliance
Foreign Supplier Verification Program compliance assistance. We help U.S. importers verify that foreign suppliers meet FDA food safety standards.
Annual Registration Renewal
Annual registration renewal management. We track renewal deadlines and handle all paperwork to keep your facility compliant.
Import Compliance Consulting
Expert guidance on FDA import compliance, import alerts, and regulatory requirements to keep your products flowing into the U.S. market.
HACCP Plan Development
Comprehensive Hazard Analysis Critical Control Point plan development to meet FDA food safety requirements and FSMA preventive controls.
Label & Ingredient Review
Expert FDA label review and ingredient compliance assessment to ensure your food products meet all U.S. labeling requirements before import.
Import Alert Assistance
Help getting your facility removed from FDA import alerts. We navigate the reinstatement process and ensure full compliance to restore your U.S. import privileges.
DUNS Request Assistance
Assistance obtaining your DUNS number (now UFI), required for FDA food facility registration. We handle the request process quickly and accurately.
Prior Notice Filing
Expert Prior Notice submission for all food imports. We ensure accurate and timely filing to prevent shipment delays and border rejections at U.S. ports of entry.
FSVP for Amazon Sellers
Specialized Foreign Supplier Verification Program compliance for Amazon sellers importing food products into the U.S. Stay compliant and keep your listings active.
Get FDA Registered in 4 Simple Steps
Our streamlined process gets your foreign food facility registered accurately and quickly.
Submit Your Information
Complete our intake form with your facility details, contact information, and food product categories.
Designate U.S. Agent
We assign a dedicated U.S. Agent to your facility — a legal requirement for all foreign registrants.
Expert FDA Filing
Our regulatory experts prepare and submit your registration through FDA's official FURLS portal.
Receive Registration Number
You receive your official FDA registration confirmation number — typically within 24–48 hours.
* 24–48 hour processing applies only to facilities with a valid DUNS Number (UFI) on file.
Core Duties of a Compliant Foreign Food Facility
Every registered foreign food facility — and its designated U.S. Agent — must perform these legally-grounded responsibilities to maintain an active, valid FDA registration.
Submit & Maintain an Active Registration
File FDA Form 3537 through the FURLS portal with accurate facility name, physical address, owner/operator, and food product categories under 21 CFR 1.231.
Designate a U.S. Agent
Appoint a U.S.-located agent reachable 24/7, per 21 CFR 1.227. The agent must accept the designation electronically through FURLS for the registration to be valid.
Obtain a Unique Facility Identifier (UFI/DUNS)
Acquire and submit a valid DUNS Number issued by Dun & Bradstreet — the FDA-recognized UFI required for every food facility registration.
Renew Biennially
Submit the registration renewal between October 1 and December 31 of every even-numbered year under 21 CFR 1.230. Late renewal results in expiration.
Update Information Within 60 Days
Per 21 CFR 1.234, report any change to facility name, address, ownership, U.S. Agent, or food categories within 60 calendar days of the change.
Permit FDA Inspection
Allow FDA inspectors to inspect the facility under Section 704 of the FD&C Act. Refusal of inspection is itself a basis for import refusal and registration action.
Comply with FSMA Preventive Controls
Implement hazard analysis and risk-based preventive controls under 21 CFR Part 117, including a written food safety plan and a Preventive Controls Qualified Individual (PCQI).
File Prior Notice for Every Shipment
Submit Prior Notice to the FDA for every food shipment to the U.S. under 21 CFR Part 1, Subpart I — required regardless of value, quantity, or sales channel.
U.S. Agent vs FSVP Importer
The U.S. Agent and the FSVP Importer are the two roles most commonly confused with foreign food facility registration — but they serve completely different legal functions.
| U.S. Agent | FSVP Importer | |
|---|---|---|
| Who designates it | The foreign food facility | The U.S. owner or consignee of the imported food (or its U.S.-based agent) |
| Who it represents | The foreign facility — acts as the FDA's communication channel | The U.S. importer — responsible for verifying the foreign supplier |
| Required by | Bioterrorism Act of 2002; FSMA | FSMA Section 301 (Foreign Supplier Verification Program) |
| Governing regulation | 21 CFR 1.227 | 21 CFR Part 1, Subpart L (§§ 1.500–1.514) |
| Primary function | Receive FDA notices, accept service, relay communications 24/7 | Conduct hazard analysis and verify suppliers meet U.S. food safety standards |
| Required for | Foreign food facility registration | Customs entry of imported food into the United States |
These are two separate, legally distinct roles, and the FDA treats them as such. The U.S. Agent is appointed by the foreign facility under 21 CFR 1.227 and represents that facility before the FDA. The FSVP Importer is the U.S.-based party named on the entry filing under 21 CFR Part 1, Subpart L, and is legally responsible for verifying that the foreign supplier meets U.S. food safety requirements before the food enters commerce. A single shipment can — and usually does — involve both: the foreign facility needs an active registration with a U.S. Agent, and the U.S. importer needs a compliant FSVP program. Most foreign exporters and U.S. importers we work with require both services to keep shipments clearing U.S. ports without delay.
DIY Registration vs FDA Registration Assistance
The FDA portal is free to use, but registering a foreign food facility correctly — and keeping it compliant — requires regulatory expertise the FDA does not provide.
| DIY (Self-File) | Professional Service | |
|---|---|---|
| Cost | FDA charges $0 — but you still must pay a separate U.S. Agent | $858/yr — includes U.S. Agent & full filing |
| Availability | You handle FURLS support hours, time zones, and language barriers | Dedicated team available across time zones, English support included |
| Domain-Specific Support | No regulatory guidance — FDA staff cannot give legal interpretations | 15+ years FDA experience, food product category guidance, FSMA expertise |
| Risk of Failure | High — wrong food categories, invalid U.S. Agent, or DUNS errors void the registration | Low — every field validated before submission to FURLS |
| Confirmation & Handling | You receive notices directly — risk of missed deadlines if you are abroad | U.S. Agent receives, translates, and relays every FDA communication 24/7 |
| Renewal & Update Tracking | You must track the biennial Oct–Dec window and 60-day update rule yourself | Automated renewal management; updates filed within FDA timelines |
Most foreign food facilities choose a professional service because the FDA's FURLS portal is not the hard part — interpreting the food product categories, maintaining a valid U.S. Agent that actually answers the FDA, tracking the biennial renewal window, and updating the registration within 60 days of any change is what determines whether your facility stays active or gets cancelled. The cost of a single detained shipment or import alert far exceeds the annual service fee. A professional service de-risks every requirement under 21 CFR Part 1, Subpart H so you can focus on production and export.
Free / Friend U.S. Agent vs FDA Registration Assistance
The FDA does not charge a fee — so why pay anything? Here is the honest comparison.
| Free / Friend U.S. Agent | Our Professional Service | |
|---|---|---|
| Government Fee | $0 — the FDA itself charges nothing | $0 government fee + $858/yr service (incl. U.S. Agent) |
| Pros | No service fee; uses someone you already know | Legal compliance, 24/7 FDA response, renewal tracking, FURLS expertise, import alert prevention |
| Cons | Friend may move, lose access, ignore FDA notices, or be unreachable — any of which voids the registration under 21 CFR 1.227 | Annual service fee — offset by avoiding even a single detained shipment |
| Best For | Almost nobody — high risk of registration cancellation | Any foreign facility serious about uninterrupted U.S. market access |
The FDA's $0 fee is real — but a "free" friend-as-agent is the most common reason foreign registrations are silently cancelled. The FDA periodically sends verification requests to U.S. Agents; if your friend ignores even one, your registration is invalidated under 21 CFR 1.241, your shipments are refused, and you are added to FDA import-alert review. The professional service fee buys legal certainty, 24/7 responsiveness, and proven FDA correspondence handling.
Foreign Food Facility Registration Terms Explained
Key technical terms you'll encounter when registering a foreign food facility with the FDA.
FDA Unified Registration and Listing System — the official online portal where food facility registrations, U.S. Agent designations, and renewals are submitted.
The official FDA food facility registration form filed through FURLS. It captures the facility name, address, owner/operator, U.S. Agent, and food product categories.
The U.S.-resident person or company designated under 21 CFR 1.227 to act as the foreign facility's official liaison with the FDA, reachable 24/7 for emergencies.
Unique Facility Identifier. The FDA currently recognizes the DUNS Number — a free 9-digit code issued by Dun & Bradstreet — as the required UFI for each facility.
FDA Food Safety Modernization Act (2011) — landmark reform that introduced biennial registration renewal, suspension authority, and preventive-controls requirements.
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 — the founding statute that established mandatory food facility registration with the FDA.
An advance notification required under 21 CFR Part 1, Subpart I for every food shipment imported into the U.S., filed before arrival at the port of entry.
Foreign Supplier Verification Program — a U.S. importer's legal duty under 21 CFR Part 1, Subpart L to verify that foreign suppliers meet U.S. food safety standards.
Detention Without Physical Examination — FDA import-alert mechanism that automatically detains shipments from facilities with known compliance issues.
An FDA published list authorizing field staff to detain shipments from specific facilities, countries, or product categories without physical inspection.
Preventive Controls Qualified Individual — a person with FSMA-recognized training responsible for developing and overseeing the facility's food safety plan.
"Serious Adverse Health Consequences Or Death to Humans or Animals" — the FSMA legal standard that triggers FDA authority to suspend a food facility registration.
Why Foreign Food Facility Registrations Fail
The most frequent failure modes that lead to registration cancellation, shipment refusal, or import alert placement — and how to avoid them.
Invalid or Unresponsive U.S. Agent
A friend, freight forwarder, or unrelated party is named but does not respond to FDA verification requests — the most common reason registrations are silently cancelled under 21 CFR 1.241.
Missed Biennial Renewal Window
Failing to renew between October 1 and December 31 of an even-numbered year automatically expires the registration. Shipments are then refused at the port of entry.
Wrong or Missing DUNS / UFI Number
Submitting an invalid, mismatched, or expired DUNS Number blocks the registration from being processed. The DUNS address must exactly match the registered physical address.
Failure to Update Within 60 Days
Changes to facility name, address, ownership, U.S. Agent, or food categories must be updated in FURLS within 60 days per 21 CFR 1.234. Late updates invalidate the registration.
Incorrect Food Product Categories
Selecting the wrong FDA product codes triggers inspector confusion, mismatched Prior Notice filings, and shipment hold at the port. Categories must match what the facility actually produces.
Refusing FDA Inspection
Under FSMA Section 306, refusing an FDA inspection of a foreign facility is grounds for immediate import refusal and import alert placement — even if registration is otherwise active.
Missing or Late Prior Notice
Every food shipment requires Prior Notice under 21 CFR Part 1, Subpart I. Missing or late filing leads to automatic refusal at the port — even for facilities with active registration.
Duplicate or Fragmented Registrations
The same facility registered twice (e.g., once by the owner, once by a forwarder) creates conflicting records, triggers FDA audit flags, and frequently leads to cancellation of both records.
Frequently Asked Questions
Everything you need to know about FDA foreign food facility registration.
FDA food facility registration is a mandatory requirement under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. All domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA.
Yes, foreign food facilities must designate a U.S. Agent when registering with the FDA. The U.S. Agent acts as a communication liaison between the FDA and the foreign facility. The agent must be physically present in the United States and available for emergency contact 24/7.
FDA food facility registrations must be renewed biennially between October 1 and December 31 of every even-numbered year, per 21 CFR 1.230. Failure to renew on time results in the registration being considered expired, and shipments can be detained at the U.S. border.
FSVP stands for Foreign Supplier Verification Program. It requires U.S. importers to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This includes hazard analysis, supplier verification activities, and corrective actions when necessary.
Yes, facilities can self-register through the FDA's online portal (FDA Unified Registration and Listing System - FURLS). However, many foreign facilities choose to work with registration assistance services to ensure accuracy, avoid common mistakes, maintain compliance, and receive ongoing support.
Once all required information is submitted, FDA registration is typically completed within 24–48 hours. The registration becomes effective immediately upon submission, and you will receive a registration number that can be used for immediate import activities.
Failure to register can result in serious consequences including: shipments being refused entry into the United States, detention of products at the border, potential legal penalties and fines, inability to export to the U.S. market, and damage to business reputation and relationships.
To register a foreign food facility with the FDA you will need: the facility's full legal name and physical address, the owner/operator name and contact information, a designated U.S. Agent's name and U.S. address, all trade names used by the facility, a valid DUNS Number (UFI), and the food product categories manufactured or processed. No fee is charged by the FDA for registration — service fees apply only when using a third-party registration assistance provider.
No. The FDA itself does not charge any fee to register a food facility. However, foreign facilities are required by law to have a U.S. Agent, and professional registration assistance services charge a fee to handle the filing accurately and maintain ongoing compliance. Our foreign food facility registration service is $429 USD per year, which includes U.S. Agent services.
Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must be registered. This includes facilities producing fresh and processed foods, beverages, dietary supplements, infant formula, seafood, dairy products, canned goods, snacks, baked goods, and pet food. Farms, retail food establishments, and restaurants are generally exempt under 21 CFR 1.226.
Yes. Under Section 102 of FSMA, the FDA has authority to suspend a food facility's registration if it determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death (SAHCODHA). A suspended facility cannot legally import or distribute food in the United States until the suspension is lifted.
A U.S. Agent is a mandatory legal requirement under 21 CFR 1.227 for all foreign food facilities registered with the FDA. The agent must be physically located in the United States and available 24/7 for emergency contact. Their role is to act as the official communication link between the FDA and your facility — receiving inspection notices, relaying regulatory communications, and ensuring your facility responds promptly to FDA inquiries.
If your FDA food facility registration lapses, your facility is no longer authorized to ship food to the United States. Shipments may be detained or refused at the U.S. border under 21 CFR 1.283, and your facility could face legal penalties. Renew biennially during the October 1 – December 31 window and maintain an active U.S. Agent to avoid any disruption to your exports.
Any changes to your facility's name, address, ownership, U.S. Agent, or food product categories must be updated in the FDA's FURLS (FDA Unified Registration and Listing System) within 60 days of the change. Keeping your registration current is a legal requirement under 21 CFR 1.234. Our team monitors and manages all updates on your behalf as part of our ongoing compliance service.
Yes. If your foreign facility manufactures, processes, packs, or holds food products that are sold to U.S. consumers — including through online platforms like Amazon, Walmart Marketplace, or direct-to-consumer websites — FDA food facility registration is required. The method of sale does not affect the registration obligation; what matters is that the food is consumed in the United States.
An FDA import alert allows FDA field staff to detain shipments from a specific facility or country without physical examination (DWPE), based on prior violations or safety concerns. If your facility is placed on an import alert, all food shipments to the U.S. can be automatically detained at the border. Maintaining an active FDA registration, a designated U.S. Agent, and full FSMA compliance is the best way to avoid being placed on — or to get removed from — an import alert list.
Our foreign food facility registration is $429 USD per year. The FDA itself charges $0 — there is no government registration fee. The $429 service fee includes: FDA Form 3537 preparation and submission through FURLS, full U.S. Agent designation and 24/7 representation, DUNS/UFI assistance, FDA registration confirmation number delivery within 24–48 hours, biennial renewal management, update filings within the 60-day window, and ongoing FDA correspondence handling. Many clients bundle this with FSVP compliance — combined, the two services give exporters and U.S. importers complete supply-chain coverage from production through customs entry. Contact us for the current bundle pricing.
Technically yes, but it is strongly discouraged. Under 21 CFR 1.227, the U.S. Agent must be a person or business physically located in the United States and reachable 24/7 to act on FDA communications. Using a friend, relative, or unrelated party who is unfamiliar with FDA timelines, FURLS access, or U.S. import procedures creates serious risk: missed inspection notices, ignored FDA verification requests, and failure to respond in time can lead to registration cancellation under 21 CFR 1.241 and shipment refusal at the port. A professional U.S. Agent treats the role as a legal obligation, not a favor.
If your U.S. Agent fails to respond to FDA communications or verification requests, your registration is treated as invalid. The FDA may cancel the registration under 21 CFR 1.241, place the facility on an import alert (such as IA 99-32 for facilities with unverified U.S. Agents), and refuse all incoming shipments at the port of entry. The FDA periodically sends electronic verification requests to designated U.S. Agents — a non-responsive agent is one of the most common causes of foreign food facility registration cancellation. Restoring the registration typically requires re-filing, a new U.S. Agent, and may require an import alert removal petition.
To change your U.S. Agent, you must update the designation in FURLS within 60 days of the change, per 21 CFR 1.234. The new U.S. Agent must accept the designation electronically through the FDA system before it becomes active — the change is not effective until that confirmation is received. We handle the entire transition: removing the previous agent in FURLS, designating our team as the new U.S. Agent, accepting the designation electronically, confirming the change with the FDA, and ensuring there is no coverage lapse between agents.
Yes. There is no minimum-shipment exemption. If your foreign facility manufactures, processes, packs, or holds any quantity of food for U.S. consumption — even a single product or single shipment — FDA food facility registration under 21 CFR 1.225 is required before that shipment can clear customs. Sample shipments, gift shipments, and first-time exports all require an active registration and Prior Notice.
Yes. Under 21 CFR 1.227, "food" includes dietary supplements, infant formula, bottled water, beverages, food additives, and animal food (pet food and livestock feed). Any foreign facility that manufactures, processes, packs, or holds these products for U.S. consumption must complete the same foreign food facility registration. Infant formula and certain animal foods have additional category-specific filings on top of the base registration.
No. FDA food facility registration is not product approval and does not imply FDA endorsement. The FDA explicitly states that registration does not constitute approval of the facility, its products, or any claims made about them. Using the FDA logo or claiming "FDA approved" on labels or marketing is a violation of FDA regulations and can trigger enforcement action.
Usually yes. If you are a foreign-owned Amazon FBA seller importing food, your manufacturing facility needs FDA food facility registration, and the U.S. importer of record (often a U.S.-formed LLC owned by the seller) must comply with FSVP under 21 CFR Part 1, Subpart L. Amazon increasingly requests both the registration confirmation and FSVP records when verifying food listings. Without both, listings can be suppressed and shipments held at customs.
Yes. You can verify status by logging into FURLS at access.fda.gov, where the registration record will show "Active," "Expired," or "Cancelled," along with the assigned registration number and U.S. Agent designation. The FDA does not maintain a public lookup tool for registration numbers — verification must be done through FURLS by the owner, operator, or U.S. Agent. If the record shows anything other than "Active," shipments will be refused at the port.
Yes. Under 21 CFR 1.225, any facility that "holds" food destined for U.S. consumption — including foreign warehouses, cold-storage facilities, and bonded depots — must register with the FDA, even if no manufacturing or processing takes place. Holding is a registration trigger on its own. Only transportation conveyances and farms (as defined in 21 CFR 1.227) are excluded.
They are two different identifiers. The DUNS Number is a 9-digit identifier issued by Dun & Bradstreet and serves as the FDA-recognized Unique Facility Identifier (UFI) tied to a specific physical address. The FDA Registration Number is an 11-digit number issued by the FDA after successful registration in FURLS. The DUNS is required to obtain the FDA registration number — but the two are not interchangeable, and neither can substitute for the other on import filings or Prior Notice.
No. FDA food facility registration is facility-specific, not company-specific. Each physical address that manufactures, processes, packs, or holds food for the U.S. market requires its own separate registration and its own DUNS/UFI number, regardless of common ownership. Operating two facilities under one registration is a frequent source of registration cancellation and import refusals.
Yes. The FDA conducts on-site inspections of foreign food facilities, prioritized by risk profile, product type, and prior compliance history under FSMA Section 306. Inspections are typically pre-announced to the facility through the U.S. Agent. Refusing an FDA inspection is a separate violation that itself triggers shipment refusal under Section 807 of the FD&C Act, regardless of whether the registration is otherwise active.
You must update the registration in FURLS within 60 calendar days of the address change under 21 CFR 1.234. The DUNS Number is tied to a physical address — so if the facility physically relocates, both the DUNS record and the FDA registration must be updated, and in some cases a new DUNS may be required. Failure to update within the 60-day window invalidates the registration, even if the rest of the information remains accurate.
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