DUNS Mandatory for FDA Registrations
Getting DUNS for FDA Registration is a requirement. Data Universal Numbering System (DUNS) is a unique nine-digit number. This unique 9-digit number identifies a business and is available to lookup on a public domain. DUN and Bradstreet first created DUNS to be able to identify companies as a part of its business credit reporting and provides other businesses with relevant corporate information about the the businesses with a DUNS number . The US Federal Government requires that all facilities/establishments that are registered with the FDA or are planning to register with the FDA should have a DUNS number.
It is important to provide the exact and accurate facility address when applying to get a DUNS number. Receiving a DUNS number after registering with DUN and Bradstreet may take up to 30 days. A DUNS number is specific to a location and hence would require a DUNS for each physical location under the establishment.