When interacting with the U.S. Food and Drug Administration (FDA), facilities and establishments involved in the manufacturing, processing, packing, or holding of food, cosmetics, drugs, medical devices, and other regulated products, are generally required to provide a Data Universal Numbering System (DUNS) Number.
The DUNS Number is a unique, nine-digit identifier issued by Dun & Bradstreet (D&B) Inc, and is used to verify a facility’s existence and location.
The DUNS Number is typically issued to:
● Corporations
● Limited liability companies (LLCs)
● Sole proprietorships
● Partnerships
● Non-profits
● Government agencies
● Educational institutions
● Foreign companies.
The DUNS Number is used globally for:
● Business credit reporting
● Government contracts and grants (including from the U.S. federal government)
● Regulatory compliance (such as with the FDA)
● Supplier and vendor validation.
The FDA began enforcing the DUNS number requirement for food facility registrations as of January 1, 2023. All domestic and foreign facilities involved in manufacturing, processing, packing, or holding food for human or animal consumption in the U.S. must provide a valid DUNS number as their Unique Facility Identifier (UFI) when registering or renewing their registration. Without it, your FDA registration cannot be validated.
Domestic and foreign drug establishments are required to have a DUNS number when registering their establishment or when creating a user fee account for various payments (OMUFA, PDUFA, GDUFA). The FDA directly pulls company information from its DUNS portal for drug registrations.
While a DUNS number isn’t always mandatory for initial medical device establishment registration, it is a mandatory requirement for submitting Unique Device Identification (UDI) data to the Global Unique Device Identification Database (GUDID). The DUNS number identifies the labeler organization in GUDID, and the FDA pulls company name and address from the D&B DUNS database for this purpose.
With the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA has new requirements for cosmetic product establishment registration and product listing.
While the primary identifier for establishment registration is the FDA Establishment Identifier (FEI) number, the FDA also requests the Responsible Person DUNS number for the address listed on the product label.
Unique Facility Identifier (UFI): The DUNS number serves as the FDA’s recognized UFI.
Location-Specific
Each physical location within a single company (branches, divisions, headquarters) typically requires its own unique DUNS number.
Verification and Traceability
The FDA uses the DUNS number to verify the legal identity and physical location of a facility, enhance traceability, prevent duplicate or fraudulent entries, and improve the accuracy and consistency of its registration databases.
Free to Obtain (with standard processing time)
You can generally obtain a DUNS number for free directly from Dun & Bradstreet (D&B) Inc or its affiliated companies around the globe. The standard processing time can take up to 30 business days, though expedited services are available for a fee.
Address Match is Crucial
For registration purposes, it’s vital that the address on your DUNS record exactly matches your registering company address to avoid FDA system errors.
Consequences of Non-Compliance
Failure to provide a valid DUNS number can result in an incomplete registration, and for foreign facilities, products may be denied entry into the U.S.
Your company’s DUNS Number is a unique nine-digit sequence. Duns numbers are assigned and administered by Dun & Bradstreet Inc (D&B) and can be obtained or verified by visiting the Dun & Bradstreet Inc website or by calling +1 866-705-5711.
