Standardized service

FDA Food Facility Registration

Any facility that manufactures, processes, packs, or holds food for the U.S. market must register with the FDA. We prepare the registration, arrange the U.S. agent appointment, and obtain the registration number; a D-U-N-S Number is required before registration.

RegulatorU.S. FDA

PrerequisiteD-U-N-S Number

Submission1-3 business days

RenewalEvery two years

On this page

What this service is

Food facility registration was established by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and has been enforced since December 12, 2003: facilities that manufacture, process, pack, or hold human or animal food for consumption in the United States must register with the FDA so the agency can locate them during inspections, recalls, and emergencies.

Since 2011, the Food Safety Modernization Act (FSMA) added a biennial renewal obligation, with the renewal window running from October 1 to December 31 of even-numbered years. Under 21 CFR 1.232(a)(2), registration requires a Unique Facility Identifier (UFI), and the D-U-N-S Number is currently the only UFI recognized by FDA.

Each registered facility receives its own 11-digit FDA food facility registration number; a company with multiple facilities must register each one separately. Farms, retail food establishments, restaurants, nonprofit food establishments, fishing vessels not engaged in processing, and facilities that only store packaged food not exposed to the environment are exempt.

Bioterrorism Act of 2002FSMA (2011)21 CFR Part 1 Subpart H21 CFR 1.232(a)(2)

Who needs it

Manufacturing facilities exporting food, beverages, or dietary supplements to the United States

Facilities that process, repack, relabel, or warehouse food destined for the U.S.

Contract manufacturers — the facility that actually produces the food must register, even if another company owns the brand

Registered facilities that need to complete the biennial renewal in an even-numbered year

Prerequisites and sequence

D-U-N-S Number→Appoint a U.S. Agent→FDA Food Facility Registration

A D-U-N-S Number must be obtained first: 21 CFR 1.232(a)(2) requires a UFI at registration, and no registration can be submitted without one.
Foreign facilities must designate a U.S. agent and complete the authorization before registration.
The facility name, address, and contact details used in registration must match the D-U-N-S record, or verification may fail.

Who holds regulatory responsibility

The registration obligation rests with the facility's owner, operator, or agent in charge, and the facility is responsible for the accuracy of the registration. We and the U.S. agent assist with preparation, submission, and later updates. FDA keeps registration information confidential; the registration number is used only in filings such as Prior Notice.

Materials we need from you

A valid D-U-N-S Number

Facility name in Chinese and English, full address, and contact details

Name and contact details of the owner, operator, or agent in charge

Activity types (manufacturing/processing/packing/holding) and applicable food categories

U.S. agent authorization details (if we are appointed as your U.S. agent)

Parent company information, if applicable

Process

01
Check the D-U-N-S Number for consistency with the facility registration details
02
Determine food categories and facility activity types
03
Complete the U.S. agent designation and authorization
04
Submit the FDA registration online
05
Obtain the 11-digit registration number and deliver the confirmation
06
Archive the registration and schedule the biennial renewal

Deliverables

Your 11-digit FDA food facility registration number

Registration confirmation and supporting certificate

A summary of the renewal cycle and obligations

Timeline

With complete information and a U.S. agent in place, registration is typically submitted and the number issued within 1-3 business days. If you do not yet have a D-U-N-S Number, that application (usually about 7-14 business days) comes first and extends the overall timeline.

Scope

What we provide

Registration preparation and consistency check against the D-U-N-S record
Coordination of the U.S. agent designation
Online registration submission
Delivery of the registration number and supporting documents
Reminders of the biennial renewal window and obligations

What is not included

D-U-N-S Number application (available as a separate engagement — see related services)
FCE registration and SID process filing for low-acid canned foods (assessed separately where applicable)
Per-shipment Prior Notice filings
Accompaniment and remediation for FDA on-site inspections

What usually follows

FDA Food Label Review FSVP Report FSVP Importer Agent

Common pitfalls

Printing the registration number on invoices or labelsFDA treats registration information as confidential; the number should only be used when filing Prior Notice. Putting it on commercial documents exposes it along the shipment chain and invites misuse.

Missing the biennial renewal windowRegistrations must be renewed every even-numbered year between October 1 and December 31. An expired registration is cancelled by FDA, arriving cargo is held, and a new registration number is required before release.

D-U-N-S record not matching the registrationIf the facility name or address in the D-U-N-S record does not match the FDA registration, verification fails and the filing is rejected. After a move or rename, update the D-U-N-S record first, then the registration.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

I own the brand but production is outsourced. Who must register?

The facility that actually manufactures the food must register. If the exporter also stores food at a facility, that facility must register too. A trader that only issues invoices while goods ship directly from the manufacturer does not need to register its office.

Should the registration number appear on invoices or labels?

No — and we advise against it. FDA keeps registration information confidential; the number is used only in filings such as Prior Notice and should not appear on commercial documents.

How often must the registration be renewed?

FSMA requires renewal every two years, from October 1 to December 31 of even-numbered years. Registrations not renewed in time are cancelled by FDA; arriving shipments will be held until the facility re-registers and obtains a new number.

Does FDA issue a certificate for registered facilities?

No. FDA does not issue registration certificates and does not approve or endorse any agent. The registration number is returned to the registered email address; the registration certificate issued by the U.S. agent serves as evidence for customers and carriers.

Related services

D-U-N-S NumberThe D-U-N-S Number is a unique nine-digit identifier for your business. It is required before FDA food facility registration and pet food facility registration. We prepare the application, follow up on verification, and keep your record consistent.Food U.S. AgentForeign food facilities must designate a U.S.-based agent when registering with the FDA, serving as the point of contact between FDA and the facility. We provide an annual U.S. agent service covering registration support, renewals, and day-to-day FDA correspondence.Food Label ReviewA line-by-line review of your label against FDA food labeling rules (21 CFR 101 and related requirements): mandatory declarations, Nutrition Facts, ingredients, and claims — with an action-points document and annotated correction suggestions so the label is compliant before it goes to market.

Disclaimer

This is a registration assistance service; issuance of the registration number is decided by FDA. This page is general information, not legal advice.