Registration of Food Facilities: The FDA Framework
Think of registration as telling FDA a facility exists and what it does — the foundation every other food requirement builds on.
Key Takeaways
- The rule lives in 21 CFR Part 1, Subpart H — from the Bioterrorism Act, amended by FSMA.
- Register if you manufacture, process, pack, or hold food for the U.S. — unless exempt.
- Foreign facilities also designate a U.S. Agent.
- Renew every two years (even years, Oct–Dec, no FDA fee).
- Keep it current — update within 60 days; cancel when a facility closes or is sold.
- Registration ≠ approval, and FDA can suspend it in serious cases.
Who Must Register — and Who's Exempt
| Generally must register | Generally exempt |
|---|---|
| Manufacturers / processors | Farms |
| Packers / repackers | Restaurants |
| Storage warehouses (holding food) | Retail food establishments |
| Foreign facilities serving the U.S. (+ U.S. Agent) | Nonprofits serving food directly to consumers |
| Co-packers and co-manufacturers | Non-processing fishing vessels; USDA-only facilities |
What the Rules Cover
Information required
Facility details, a DUNS number, contacts, food categories, and activity types — an information submission, not a document upload. See what to prepare.
U.S. Agent
Foreign facilities must name a U.S. Agent as FDA's point of contact. See U.S. Agent for food companies.
Biennial renewal
Renew every even-numbered year, Oct 1–Dec 31, no fee. See renewing your registration.
Updates, Cancellation & Suspension
Registration isn't "set and forget." The guidance treats it as a living record with a lifecycle:
Update (within 60 days)
A change to required information — address, contacts, U.S. Agent — generally must be updated within 60 calendar days (21 CFR 1.234).
Cancel (closed or sold)
When a facility stops operating or changes owners, the registration is cancelled — the former owner cancels, the new owner registers (21 CFR 1.235).
Suspend (serious risk)
FDA can suspend a registration if the facility's food could cause serious harm (the SAHCODHA standard), halting U.S. distribution.
The Registration Path
Confirm you must register
Check your activity against the exemptions — or use the checklist.
Gather the information
Facility details, DUNS, contacts, categories, activity types — see what to prepare.
Designate a U.S. Agent
Foreign facilities name a U.S. Agent and obtain consent before submitting.
Submit via FURLS
Register through FDA's system and save the registration number and PIN.
Keep it current
Update within 60 days of changes; cancel if the facility closes or is sold.
Renew every two years
Renew each even year, Oct–Dec, to keep the registration active.
Get Your Facility Registered — and Kept Current
FDA Registration Assistance prepares and submits your registration, serves as your U.S. Agent, and manages renewals and updates — so the record stays accurate and your shipments keep moving.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Trusted by food companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions
1. What is FDA's guidance on registering food facilities?
FDA's plain-language explanation of the registration requirement — who must register, what to provide, and how to stay current. The binding requirement is in 21 CFR Part 1, Subpart H, implementing the Bioterrorism Act as amended by FSMA.
2. Who must register a food facility?
Any domestic or foreign facility that manufactures, processes, packs, or holds food for the U.S., unless exempt. Foreign facilities also designate a U.S. Agent. Our checklist walks it through by category.
3. Which facilities are exempt?
Commonly farms, restaurants, retail food establishments, nonprofits serving directly to consumers, certain non-processing fishing vessels, and USDA-only facilities. Private residences aren't facilities. Exemptions are specific, so check borderline cases.
4. What information does registration require?
Facility details, a DUNS number, parent company and trade names, the owner/operator/agent-in-charge, food categories, activity types, and (foreign) U.S. Agent details. No certificates are uploaded — see our documents-needed guide.
5. Do foreign facilities need a U.S. Agent?
Yes — a U.S. Agent with a real U.S. address acts as FDA's contact for the facility, including on inspections. The agent must consent, and FDA confirms the designation.
6. How often must a registration be renewed?
Every two years, Oct 1–Dec 31 of even-numbered years, with no FDA fee. A registration that isn't renewed is treated as expired, which can stop imports.
7. What if my facility information changes?
A change to required information generally must be updated within 60 calendar days (21 CFR 1.234). Keeping the record accurate avoids problems during import review.
8. When is a registration cancelled?
When the facility stops operating or changes ownership — the former owner cancels and the new owner registers (21 CFR 1.235). A stale registration for a closed or sold facility creates inaccuracies.
9. Can FDA suspend a registration?
Yes — under FSMA, FDA can suspend if a facility's food has a reasonable probability of causing serious harm or death (the SAHCODHA standard). A suspended facility can't distribute food in the U.S. until it's resolved.
10. Is registration the same as FDA approval?
No — it tells FDA the facility exists and what it does; it isn't approval or certification. "FDA approved" based on registration is inaccurate.
11. Is registration the same as FSVP?
No — registration is about the facility that makes or holds food; FSVP is the U.S. importer's duty to verify foreign suppliers. A supply chain can need both, handled separately.
12. When must registration be completed?
Before the facility begins making or holding food for the U.S., and before that food is imported or distributed. FDA checks registration during import review, so it must be in place first.
13. Can I handle registration myself?
Yes, directly through FURLS. Many use a firm to avoid common errors (wrong categories, DUNS mismatches, missed renewals) and to have a U.S. Agent in place. The requirement is the same either way.
14. How does FDA Registration Assistance help?
It prepares and submits registrations, serves as U.S. Agent, and manages renewals and updates for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
