DUNS Number for FDA Registration FAQ

DUNS Number Requirements for FDA Food Facility Registration

Effective December 31, 2022, the United States Food and Drug Administration implemented a mandatory requirement for all food facilities to provide a valid DUNS Number (Data Universal Numbering System) as part of their FDA food facility registration. This regulatory change affects both domestic and foreign food establishments seeking to register or renew their FDA registration under the Federal Food, Drug, and Cosmetic Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

What is a DUNS Number?

The DUNS Number is a unique nine-digit identification number issued and maintained by Dun & Bradstreet (D&B), the world's leading commercial data and analytics provider. This identifier serves as a universal standard for tracking business entities globally and is used by government agencies, financial institutions, and commercial enterprises to verify business legitimacy and establish credit profiles.

Key characteristics of DUNS Numbers: DUNS Numbers are issued exclusively by Dun & Bradstreet—no other organization has authority to assign them. Each distinct physical location of a business receives its own unique DUNS Number, making them site-specific identifiers. These numbers are permanent and do not change even if business ownership or name changes. The standard DUNS Number application is free to obtain for most businesses (though expedited processing may incur fees), and DUNS Numbers are recognized internationally across more than 200 countries and territories.

FDA Regulatory Requirement: DUNS as Unique Facility Identifier

Under Title 21 Code of Federal Regulations Section 1.232(a)(2) [21 CFR 1.232(a)(2)], the FDA formally designated the DUNS Number as the only acceptable Unique Facility Identifier (UFI) for food facility registration purposes. This regulation eliminates alternative identification methods and standardizes facility tracking across FDA's food safety surveillance systems.

Before December 31, 2022, DUNS Numbers were recommended but not mandatory for FDA food facility registration. After December 31, 2022, DUNS Numbers became mandatory—FDA stopped accepting registrations and renewals without valid DUNS Numbers. Currently, all new registrations and biennial renewals must include a DUNS Number matching the facility's physical location. This mandate applies to all food facilities subject to FDA registration requirements, including manufacturers, processors, packers, and storage facilities handling food for human or animal consumption in the United States.

Why FDA Requires DUNS Numbers

The FDA's adoption of DUNS Numbers as the standard UFI serves multiple food safety and regulatory objectives. The site-specific nature of DUNS Numbers prevents facilities from creating multiple registration entries for the same physical location, eliminating duplicate registrations. DUNS Numbers provide verified business and location information, reducing errors in FDA databases and ensuring accurate facility identification. During food safety emergencies, FDA can rapidly identify and contact affected facilities using DUNS-linked contact information, enhancing outbreak response capabilities.

Customs and Border Protection (CBP) can efficiently verify FDA registration status for foreign shipments using DUNS Numbers, streamlining import surveillance. DUNS Numbers facilitate coordination between FDA, USDA, state agencies, and other food safety authorities through interagency data sharing. Additionally, this requirement creates consistency with other federal programs, as many federal grants, contracts, and registrations already require DUNS Numbers, creating uniformity across government systems.

Site-Specific DUNS Number Requirement

Critical requirement: The DUNS Number must correspond to the exact physical address of the food facility being registered with FDA. Each distinct physical location where food manufacturing, processing, packing, or holding operations occur requires its own DUNS Number. Companies operating multiple facilities cannot use a single corporate headquarters DUNS Number for all locations.

For multi-facility operations, a food company with manufacturing plants in three states needs three separate DUNS Numbers—one for each facility address. The corporate office DUNS Number cannot be used for the manufacturing facility DUNS Number, even if both are owned by the same company. If two legally distinct companies operate food businesses at the same physical address, each requires its own DUNS Number. Food storage warehouses that are geographically separate from manufacturing facilities need their own DUNS Numbers as well.

Important distinction: Do not confuse the DUNS Number with your company's tax identification number (EIN, TIN, or foreign tax ID). These are completely different identifiers serving different purposes. FDA requires the DUNS Number specifically, not tax identification numbers.

How to Obtain a DUNS Number

Dun & Bradstreet offers multiple pathways for businesses to request DUNS Numbers. The standard process is free of charge, though expedited services are available for an additional fee.

For Domestic US Facilities: Visit the official Dun & Bradstreet website at www.dnb.com and locate the DUNS Number request form. Alternatively, you can call D&B at 1-866-705-5711 to request a DUNS Number by phone. You will need to provide required business information including legal business name (as registered with state/federal authorities), trade name or "doing business as" (DBA) name if different, complete physical address of the facility (not a PO Box—must be the actual location where operations occur), mailing address if different, primary contact name, phone number and email address, company headquarters address if the facility is a branch location, number of employees at this specific location, and primary business activities (food manufacturing, processing, packing, holding).

Standard DUNS Number requests typically process within 30 business days. D&B will verify the information provided and may contact you for clarification. Once approved, you will receive your nine-digit DUNS Number via email or mail. Expedited processing (1-5 business days) is available for a fee.

For Foreign Facilities: International food facilities exporting to the United States follow the same general process but should access D&B's international portal or contact their regional D&B office. Processing times for foreign DUNS Number requests may extend to 45-60 business days due to additional verification steps. Ensure that your DUNS Number application lists the facility's physical address in your home country, not your US Agent's address. Your US Agent's information is collected separately during FDA food facility registration.

Verifying and Updating DUNS Number Information

After receiving your DUNS Number, verify that the information in D&B's database accurately reflects your facility details. Incorrect or outdated information can cause FDA registration delays or rejections. To verify your DUNS Number details, request a free D&B business information report at www.dnb.com, review the physical address, legal name, and contact information for accuracy, contact D&B customer service to update your record if corrections are needed, and allow 2-4 weeks for updates to process before submitting your FDA registration.

If your facility relocates to a new address, changes its legal business name, or undergoes ownership changes, you must notify D&B to update your DUNS Number record. Note that if you physically move to a new location, you may need to obtain a new DUNS Number for the new address, as DUNS Numbers are site-specific.

Expert Assistance with DUNS Numbers and FDA Registration

Navigating DUNS Number requirements and FDA food facility registration can be complex, particularly for foreign facilities, multi-location companies, and businesses new to FDA regulations. Liberty Management Group provides comprehensive support throughout the entire process.

Our DUNS Number and FDA Registration Services Include: DUNS Number application guidance and verification of DUNS Number accuracy in D&B's database, complete FDA food facility registration and biennial renewal services, US Agent services for foreign food facilities, multi-facility registration coordination for companies with multiple locations, DUNS Number validation troubleshooting and error resolution, and registration deadline tracking and renewal reminders.

Since the DUNS Number mandate took effect in 2022, we have successfully assisted hundreds of food facilities—both domestic and international—in obtaining DUNS Numbers and completing FDA registrations without delays or complications.

For assistance with DUNS Number guidance or FDA food facility registration, contact our regulatory specialists at info@fdahelp.us. We ensure your facility obtains the correct DUNS Number and completes FDA registration accurately and on time.