Who needs to register with FDA?
Key facts from FDA food-facility registration rules.
See our U.S. Agent representation service.
- Facilities must register before they begin manufacturing, processing, packing or holding food for consumption in the United States (21 CFR 1.230(a)).
- Registrations must be renewed from 1 October through 31 December of each even-numbered year (21 CFR 1.230(b)).
- FDA charges no fee to register or renew a food facility (21 CFR 1.231(c)).
- A foreign facility must name a U.S. agent (21 CFR 1.232(c)).
- A registration that is not renewed expires (21 CFR 1.241(b)).
FDA Facility Registration
We handle the full FDA facility registration process for food, beverage, dietary supplement and cosmetic facilities.
- Preparing and submitting your FDA facility registration
- Ensuring accuracy in facility details to avoid delays or errors
- Managing renewals during the biennial renewal period
US Agent Representation
Foreign facilities must appoint a US Agent as their official contact with the FDA, and we provide that representation.
- Acting as your official US Agent for FDA communications
- Addressing any FDA enquiries or issues on your behalf
- Ongoing monitoring of regulatory updates relevant to your operations
FDA Registration Agent
Biennial Renewal Assistance
FDA registration must be renewed every two years, and we manage the renewal so your registration stays active.
- Automatic reminders and tracking of renewal deadlines
- Submission of biennial renewal applications
- Updates to facility information, if necessary
D-U-N-S Number Assistance
The FDA requires foreign facilities to provide a D-U-N-S Number for registration, and we can help you obtain one if you don't have it.
- Guidance on obtaining a D-U-N-S Number
- Accurately matching your DUNS number with your FDA registration
- Ensuring your facility registration is complete and accepted
Compliance Monitoring
We keep you updated on FDA regulatory changes that may affect your registration or operations, and advise on any changes needed.
- Regular monitoring of FDA regulations and guidance
- Proactive alerts for changes that may require action
- Support for adapting to new requirements
Additional FDA Compliance
Our FDA registration service can be paired with further compliance support as part of a wider FDA compliance package.
- FDA Labelling Compliance Reviews for food, supplements and medical devices
- FSVP Agent Services for US importers & distributors
- Customs Documentation & Prior Notice Filing
How the registration process works
Registering with the FDA can be confusing, so we guide you through the process from start to finish.
- 1
Get in touch and tell us about your facility
- 2
We send you a short, simple questionnaire to collect the facility details
- 3
We work with the FDA to get your facility registered
- 4
We are appointed as your US Agent and communicate with the FDA on your behalf
- 5
You receive your FDA registration number and certificate, and we continue to maintain your registration
Ongoing compliance support
Time-Saving
We handle the registration paperwork and renewals, so you can focus on running your business.
Regulatory Assurance
Stay on top of FDA registration requirements, including biennial renewals and facility updates.
Peace of Mind
Reduce the risk of detentions, fines and operational disruption at the US border.
What you'll need
Have these facility details ready so registration or renewal goes through cleanly.
- Accurate facility detailsName, address and activities that match your other records.
- A D-U-N-S NumberMatched exactly to the details on your FDA registration.
- A US AgentRequired for foreign facilities to handle FDA communications.
- Your renewal timingKnow when the biennial renewal period falls for your facility.
- Completed questionnaireOur short form collects the facility details we submit.
Official sources
If your foreign food facility also needs a US contact, see our FDA US Agent service.
Related services: FDA US Agent service · 2026 renewal checklist