What is a DUNS Number USFDA?

A DUNS number (Data Universal Numbering System) is a unique 9-digit identifier assigned to businesses by Dun & Bradstreet (D&B). It is widely used to identify and verify entities globally. For the U.S. Food and Drug Administration (USFDA), the DUNS number serves as a Unique Facility Identifier (UFI) required for facility registration and compliance purposes, particularly for food, drug, and medical device facilities.

Importance of a DUNS Number USFDA

1. Facility Identification:
   Each manufacturing, processing, or storage facility must have a unique DUNS number, ensuring accurate tracking and identification of operations.
   
2. Regulatory Compliance:
   The DUNS number is mandatory for facilities registering with the FDA, as per 21 CFR 1.232. It is required for food facilities, drug manufacturers, and those involved in the Foreign Supplier Verification Program (FSVP).
   
3. Verification and Credibility:
   FDA uses the DUNS number to validate the legitimacy of facilities and maintain accurate registration databases【343】【344】.

How to Obtain a DUNS Number

Steps to Apply:

1. Visit the D&B Portal: Use the D&B Import Safety Portal to request a new DUNS number.
2. Provide Business Information: Fill out details like facility name, address, contact information, and legal structure.
3. Submit Application: After reviewing, submit your request.
4. Processing Time: Standard requests take 30–45 days, while expedited services are available for a fee.

Key Points:

• DUNS numbers are free when requested through standard channels.
• Each facility location must have its own DUNS number, even if part of the same company【343】【345】.

Common Issues with DUNS Numbers

1. Invalid or Expired Numbers: Ensure the number is updated and valid for FDA registration.
2. Incorrect Facility Association: Verify that the DUNS number aligns with the correct facility address and details.
3. Rejection by FDA: Contact D&B to resolve mismatches or errors if a number is not accepted during FDA registration【346】.

Conclusion

The DUNS number is an essential tool for businesses interacting with the FDA. It facilitates smooth registration, compliance, and validation processes, especially for entities in the food, drug, and medical device industries. Ensuring accurate and timely application or updates of a DUNS number helps businesses avoid regulatory issues and maintain operational efficiency.

For more information, visit the FDA’s DUNS resource page or Dun & Bradstreet’s website【343】【344】【347】.

FAQs 

1. What is a DUNS number, and why is it required by the USFDA?

A DUNS number is a unique 9-digit identifier provided by Dun & Bradstreet (D&B). The USFDA requires it to identify and verify manufacturing, processing, and storage facilities for compliance and tracking purposes.

2. How can I apply for a DUNS number for FDA registration?

You can apply via the D&B Import Safety Portal by providing facility details. Standard processing takes 30–45 days, but expedited services are available for a fee.

3. Is there a fee for obtaining a DUNS number?

No, obtaining a DUNS number is free through the standard application process offered by D&B.

4. Can multiple facilities under the same company use the same DUNS number?

No, each facility location must have a unique DUNS number, even if they belong to the same company.

5. What should I do if my DUNS number is rejected during FDA registration?

Ensure the number is valid and associated with the correct facility details. Contact D&B for assistance in resolving mismatches or errors if issues persist.

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