D-U-N-S & F E I

D-U-N-S  &  F E I

 

Data Universal Numbering System (DUNS)

DUNS number is a unique nine digit identification number, provided by Dun & Bradstreet for each physical business location. DUNS users include the European Commission, the United Nations and the United States government. More than 50 global, industry, and trade associations recognize, recommend, or require DUNS. The DUNS database contains over 100 million entries for businesses throughout the world.

FDA will require Data Universal Numbering System (D-U-N-S) numbers for both the facility or site and the registrant owner of the facility or site if the facility or site is in a different location than the registrant owner location. Each distinct physical location of an entity (e.g., branch, division, and headquarter) would be assigned a different D-U-N-S number.
 

The site-specific D-U-N-S number is a widely recognized business identification tool and serves as a useful resource for FDA in identifying and verifying certain business information submitted by a user. If no D-U-N-S number has been assigned, a business entity may obtain one at no cost directly from Dun & Bradstreet. A new number may be obtained, or an existing number verified, by phone or online. Existing facilities D-U-N-S numbers may also be verified on FDA’s current registration site for drug establishments.

Note: It takes Dun & Bradstreet approximately 30 business days to process a new D-U-N-S number and communicate it via email. A business entity may receive a  D-U-N-S number in approximately 10 business days for an expedited service fee.

Facility Establishment Identifier (FEI)

Facility Establishment Identifier (FEI), a unique identifier designated by FDA to assign, monitor, and track inspections of regulated firms. FDA will assign only one FEI number to separate buildings if they are in close proximity and if the activities conducted in each building are closely related to the same business enterprise, are under the supervision of the same local management, and are capable of being inspected by FDA during a single inspection.

A business entity that has previously obtained an FEI number may verify its FEI number on FDA’s registration site for drug establishments.