Leading Firm for FDA Food Facility Registration
The filing itself is free with FDA. The value of a firm is getting it right — and never letting it lapse.
Key Takeaways
- Required for facilities that manufacture, process, pack, or hold food for U.S. consumption.
- Form 3537 via FURLS, with a DUNS number as the Unique Facility Identifier.
- Foreign facilities need a U.S. Agent with a real U.S. address.
- Biennial renewal — even years, Oct 1–Dec 31; miss it and the registration expires.
- FDA's fee is $0 — any cost is a professional service fee, not a government charge.
- Registration ≠ approval — and FDA can suspend a registration under FSMA.
Who Must Register — and Who's Exempt
The requirement comes from the Bioterrorism Act, so FDA can rapidly identify food facilities in a safety emergency. It reaches most of the supply chain, with some clear exemptions:
| Must register | Generally exempt |
|---|---|
| Food manufacturers & processors | Farms |
| Packers & repackers | Restaurants |
| Warehouses & cold storage that hold food | Retail food establishments |
| Foreign facilities shipping food to the U.S. | Nonprofit food establishments that prepare/serve food |
| Both domestic and foreign facilities | Non-processing fishing vessels; USDA-only facilities |
How Registration Actually Works
Form 3537 in FURLS
Registration is submitted through the FDA Unified Registration and Listing System, capturing facility details, activities, and food product categories.
DUNS / Unique Facility Identifier
A DUNS number is required and must match the facility's name and address exactly — a frequent cause of rejected registrations.
U.S. Agent (foreign)
Foreign facilities designate a U.S. Agent — a real U.S. address, reachable in business hours — as FDA's contact.
Renewal & Suspension
Biennial renewal
Renew every two years, October 1–December 31 of even-numbered years — no FDA fee. Miss the window and the registration expires, so the facility is treated as unregistered and shipments can be held or refused. It's the single most common avoidable lapse.
Suspension authority
Under FSMA, FDA can suspend a registration if the facility's food has a reasonable probability of serious adverse health consequences or death. A suspended facility can't import, export, or introduce food into U.S. commerce.
What It Costs
FDA charges nothing to register or renew a food facility. Anyone telling you the government fee is higher is mistaken.
A flat fee for accurate registration and setup — the professional work, not access to a free system.
How to Register a Food Facility
Confirm you must register
Check that your facility handles food for U.S. consumption and isn't exempt (farms, restaurants, retail).
Obtain a DUNS number
Get the DUNS that serves as your Unique Facility Identifier, matching name and address exactly.
Designate a U.S. Agent
For foreign facilities, name a U.S. Agent with a real U.S. address as FDA's contact.
Complete Form 3537 in FURLS
Submit facility details, activities, and food product categories through FURLS.
Receive your registration number
FDA issues a number on acceptance; keep the credentials for renewal and updates.
Renew every two years
Renew in the even-year Oct–Dec window and update whenever facility information changes.
Register With a Team That Handles the Whole Lifecycle
We complete your food facility registration accurately, serve as your U.S. Agent, manage the biennial renewal so it never lapses, and support FDA inquiries — with 15+ years of experience and 1,000+ clients across 135+ countries.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Flat professional fee, no surprises.
Frequently Asked Questions
1. What is FDA food facility registration?
Registering your facility with FDA (21 CFR Part 1 Subpart H) when it manufactures, processes, packs, or holds food for U.S. consumption. It came from the Bioterrorism Act and applies to domestic and foreign facilities serving the U.S. market.
2. Does FDA charge a fee to register?
No — FDA charges nothing to register or renew a food facility (unlike device registration, which has an annual fee). Any cost is a professional service fee, not a government charge.
3. Does registration mean I'm "FDA approved"?
No. Registration tells FDA your facility exists and what it does — it isn't approval, endorsement, or certification. Claiming "FDA approved" because you registered is inaccurate.
4. Who must register?
Domestic and foreign facilities that manufacture/process, pack, or hold food for U.S. consumption — manufacturers, processors, packers, warehouses, cold storage. Foreign facilities also need a U.S. Agent.
5. Are any facilities exempt?
Yes — farms, restaurants, retail food establishments, nonprofit food establishments that prepare/serve food, non-processing fishing vessels, and USDA-only facilities are generally exempt.
6. What are Form 3537 and FURLS?
Form 3537 is the registration form, submitted through FURLS — FDA's online registration portal — capturing facility details, activities, and food product categories.
7. Do I need a DUNS number?
Yes — a Unique Facility Identifier is required, and FDA recognizes the DUNS number. It must match the facility's name and address exactly, or the registration can be delayed.
8. Do foreign facilities need a U.S. Agent?
Yes — a U.S. Agent with a real U.S. address (no P.O. box), reachable in business hours, who serves as FDA's contact and emergency point of communication.
9. How often is registration renewed?
Every two years, October 1–December 31 of even-numbered years, with no FDA fee. Miss it and the registration expires — the facility is treated as unregistered.
10. What happens if I don't renew?
The registration expires, so the facility is unregistered — for foreign facilities, food generally can't legally enter U.S. commerce, causing holds and refusals until it's restored.
11. Can FDA suspend a registration?
Yes — under FSMA, if a facility's food has a reasonable probability of serious adverse health consequences or death. A suspended facility can't import, export, or introduce food into U.S. commerce.
12. Can I register myself?
Yes. Many still use a firm to avoid common pitfalls (wrong categories, DUNS mismatches, missing U.S. Agent, lapsed renewals) and to keep the registration active and accurate over time.
13. How much does it cost with you?
A flat professional fee of $858 for accurate registration and setup. Since FDA charges nothing to register, that fee is entirely for the professional service — done right, with U.S. Agent and renewal support.
14. What makes you a leading firm for this?
Accurate full registration, U.S. Agent representation, biennial renewal management so it never lapses, correct categories and DUNS, and FDA-inquiry support — with 15+ years and 1,000+ clients across 135+ countries.
15. How do I get started?
Contact FDA Registration Assistance at info@fdaregistrationassistance.com or call +1 (928) 275-8333 with your facility details and food products.
