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Registrar Corp

World's Leading FDA Compliance Experts

DUNS Numbers and Why FDA Requires Them: A Guide

Nov 1, 2023

As a food facility or drug establishment you’ve likely wondered what a DUNS number is. In recent years, they’ve become an important part of complying with U.S. Food and Drug Administration (FDA) regulations.  This guide will explore what DUNS numbers are, why they are crucial for FDA registration and importing goods, and how you can obtain one. 

 

What is a DUNS Number? 

A D-U-N-S, or Data Universal Numbering System, number is a unique 9-digit code that identifies U.S. businesses.

Dun & Bradstreet, a business intelligence agency and credit bureau, created the numbering system in 1963 to track business credit scores. Today, Dun & Bradstreet collects company information, such as their:

  • Phone number and address 
  • Partners, vendors, and subcontractors 
  • Headquarters and branches  

Dun & Bradstreet also collects data about companies’ financial health and stability. 

Financial institutions, regulatory agencies, federal governments, and other organizations can use this system to identify businesses and learn more about them. DUNS numbers are most often used to build and check business credit and for companies who may want to: 

  • Apply for a loan 
  • Apply for credit 
  • Apply to become a company’s vendor or supplier 
  • Bid on local, national, or international government contracts 

Anyone who knows a business’s legal business name, state, and country, can look up your DUNS number and access your company information and credit reports. 

Over 240 million small and large businesses worldwide use DUNS numbers, including many government agencies, global chains, and international organizations. 

 

Why Does My Business Need a DUNS Number?  

While you don’t need a DUNS numbers to conduct business in the U.S. or globally, many government, financial, and regulatory organizations will ask you to provide one. Not only do they create a standardized credit scoring system and information database for businesses, but DUNS numbers also fill an important role in many business activities. 

 

Credit Reporting

Businesses applying for funding or credit must have a DUNS number to share with potential lending institutions. This is similar to when an individual has their credit score checked by a bank or lender when applying for a loan. 

The business credit report attached to a company DUNS number contains a variety of financial scores, such as: 

  • Viability Rating: Credit rating system for financial health based on current and future health as well as the potential for bankruptcy or other major financial changes 
  • Failure Score: Predicts a company’s potential interactions with creditors based on business and payment history and industry 
  • Delinquency Score: Score that predicts a business’s likelihood of making delinquent payments, not paying creditors, or seeking legal relief from creditors 

This report also includes any public filings: bankruptcies, lawsuits, liens, judgments, and more. 

 

International Regulations 

DUNS numbers play a crucial role in regulatory compliance. Worldwide, DUNS numbers have more recently been requested by organizations like the European Commission, United Nations (UN), and World Customs Organization (WCO).  

Food facilities and drug establishments that register with FDA are also now required to obtain a DUNS number. 

 

DUNS and FDA 

The Food, Drug, and Cosmetics (FD&C) Act of 2016 requires food facilities to submit a Unique Facility Identifier (UFI) when registering with FDA or renewing their registration. FDA named DUNS numbers as the only acceptable UFI, making it mandatory for all food facilities eligible for FDA registration to obtain a UFI by the 2020 renewal period.

 As of December 31, 2022, all food facilities registered with FDA must have an active DUNS number. FDA has been requiring DUNS numbers for drug establishments since 2009. 

FDA requires a separate DUNS number for each facility or establishment rather than per company. 

Foreign Supplier Verification Program (FSVP) importers must also obtain a DUNS number as a UFI to provide customs agents at all ports of U.S. entry, even if they don’t have to register with FDA. They also need to confirm that their suppliers have a valid FDA registration 

As of September 15, 2023, FDA will not assign a food facility registration number without a valid DUNS number. This deadline does not apply to drug establishments. If you recently filed an updated FDA registration, FDA also conducts an automatic UFI verification after updates are submitted to existing food facility registrations.  

Not providing a valid DUNS number when registering or renewing with FDA may result in your registration being suspended or canceled. This could prevent you from being able to legally market or sell food products in the U.S. For food importers, this could cause shipments to be denied entry.

 

How Do I Obtain a DUNS Number? 

 You can request a DUNS number for your FDA facility registration directly from the Dun & Bradstreet online portal. 

Step 1 

Choose I need a UFI to register with the FDA” from the available options, then fill in the requested information. This may include: 

  • Preferred email 
  • First and last name 
  • Job Title 
  • Legal business name 
  • Business address 
  • Business phone number 

You will be prompted to look up your business and confirm that you don’t already have a DUNS number. If you can’t find your legal business name in the provided list, create a request for a new DUNS number. 

Step 2 

Choose two documents from the official list to verify your identity and fill in your business, business structure, and facility type information before uploading them. Once you’re done, you can wait the normal processing time (30 days) or pay for expedited service. 

The portal may also prompt you to set up an account if you don’t have one already. 

If you have multiple business addresses, you will need to apply for a unique DUNS number for each one. The online portal does include a batch request option so you can submit multiple requests at once.

 

Updating DUNS Number or Profile Information 

FDA requires that all registration information be accurate and current. If you’ve recently made any changes, such as moving facilities or changing ownership, you will need to update your DUNS number information or apply for a new one. 

FDA will only accept your updated registration conditionally pending the agency’s verification that your DUNS number is acceptable.. If you fail to provide an updated DUNS number within 30 days, FDA will cancel your facility or establishment registration on the grounds of an unacceptable UFI.  

In some cases, you might be able to fix the discrepancy and request that your canceled number be reinstated. But you may also need to re-register your facility or establishment so you can be assigned a new registration number.  

 

Hiring a Professional for DUNS Assistance 

You can always apply for a DUNS number yourself. But keeping it and your company profile updated can be time-consuming, especially if you have multiple facilities. Working with regulation specialists not only simplifies the application process but also helps you successfully maintain your FDA registration and avoid noncompliance. 

 

Get DUNS Number Assistance with Registrar Corp 

At Registrar Corp, we help U.S. and international companies comply with FDA regulations. Let us work with you to obtain and maintain your DUNS numbers.

We offer DUNS assistance as part of our FDA Registration service, which also includes: 

  • FDA Registration and Renewal assistance 
  • 24/7 U.S. Agent representation 
  • Detention assistance 
  • Prior Notice filing 
  • Mock FDA Inspections (for an additional reduced fee) 

For non-U.S. companies exporting to the U.S., we offer a full-spectrum U.S. Agent service that includes DUNS number assistance. 

Learn more about our DUNS assistance services today. 

 


Frequently Asked Questions about DUNS Numbers 

 

Is a DUNS number the same as a tax or identification number? 

No. A DUNS number doesn’t replace any tax or identification numbers. It is issued by credit bureau Dun & Bradstreet for business credit reporting purposes and not related to your tax situation. 

 

How much does a DUNS number cost? 

Dun & Bradstreet offers DUNS numbers free of charge through their online portal. But you can pay an extra fee for expedited processing.

 

How long does it take to get a DUNS number? 

Dun & Bradstreet’s processing times can vary based on several factors including: 

  • Publicly available information to verify a company’s existence and operations 
  • Facility’s response time to Dun & Bradstreet’s communication attempts. A representative typically needs to communicate with an officer or manager onsite at the facility before assigning a DUNS number for FDA purposes 
  • DUNS investigation procedures which are unique to each global Dun & Bradstreet partner 

Normal processing time for a DUNS number is 30 days, but there are cases that take even longer to resolve.

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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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