DUNS and FEI are part of self-identification of generic drug facilities,
sites, and organizations. It is requirement of GDUFA. This article is about brief
description regarding DUNS and FEI numbers.
DUNS number
The complete form of DUNS is Data Universal Numbering System. It is
also abbreviated as D-U-N-S. it is a unique nine-digit number
for identifying business. This system was originally created in year 1962. DUNS
is one of the self-identification requirement in GDUFA. It is a proprietary
system developed and regulated by Dun
& Bradstreet (D&B) that assigns a
unique numeric identifier, referred to as a "DUNS number" to a single
business entity. It is standard worldwide with users including United
Nations, the European Commission, United States government.
USFDA requires 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. A D-U-N-S number is required to uniquely identify the registrant (the owner or operator) and each physical location of the business’s facility or site (e.g., branches, divisions, and headquarters).
The DUNS number is a nine-digit number, issued by Dun & Bradstreet,
assigned to each business location in the D&B database, having a unique,
separate, and distinct operation for the purpose of identifying them.
This
information is included in manufacturing information section of dossier, DMF or
while completing various forms which require organizations details.
Tentative time required for obtaining DUNS number is 30 working days. A
business entity may receive a D-U-N-S number in approximately 10 business days
for an expedited service fee.
FEI Number:
FEI means FDA Establishment Identification number. It is a unique identifier issued by FDA to track inspections of
the regulated establishment or facility. FEI numbers are also used to track
GDUFA facility fee payments. The FEI number can be
requested at no cost from FDA. Like DUNS, even FEI number is included in
manufacturing information section of dossier, DMF or while completing various
forms which require organizations details.
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