The document discusses D-U-N-S numbers and FEI numbers, which are required for self-identification of generic drug facilities and organizations under the Generic Drug User Fee Amendments of 2012. A D-U-N-S number is a unique 9-digit identifier for locations assigned by Dun & Bradstreet. An FEI number is assigned by the FDA to track inspections of regulated firms. The document provides information on obtaining these numbers and the penalties for failing to self-identify facilities.

1. Presented By – Ms. Shikha Jain
Date –
Venue -
Presentation on
D-U-N-S® Number & FEI Number

2. BACKGROUND
 Self identification of generic drug facilities,
Sites and organizations:
 In GDUFA 2012, FDA’s requirement of submission
of Self identification information by human generic
drug facilities, Sites and organizations is listed.
 On July 9, 2012 GDUFA was designed;
To speed the delivery of safe and effective
generic drugs to the public and,
To reduce costs to industry.

3. BACKGROUND
 FDA is establishing a new system for electronic
self-identification of generic industry facilities and
organization.
 Therefore, entities that are required to register
and list (under section 510 of Federal Food, drug
And cosmetic Act or section 351 of the Public
Health Service Act) are required to Self-identify
with GDUFA.
 Once self identification procedure has been
completed, FDA will determine facility fees that is
required to be paid annually.

4. Who is required to Self Identify
1
• Facilities that manufacture or intend to manufacture,
human generic drug APIs or FDFs or both
2
• Sites and organizations involved in packaging and
labeling of FDF into primary container / closure system
3
• Sites involved in re-packaging and labeling of FDF into
primary container / closure system of different size
4
• Bioequivalence (BE) / bioavailability (BA) sites

5. Self
identification
D-U-N-S®
Number
FEI Number
Information required for
Self identification

7. background
 The federal government requires that all
applicants for federal grants and cooperative
agreements have a D-U-N-S® Number.
 The federal government will use D-U-N-S®
Number to identify related organizations that are
receiving funding under grants and cooperative
agreements

8. INTRODUCTION
 In 1962, Dun & Bradstreet established business
identification database in the form of D-U-N-S®
Number: 9 digit identification number
D - Data
U - Universal
N - Numbering
S - System
D-U-N-S® may be issued with or without dashes for
readability: XX-XXX-XXXX OR XXXXXXXXX

9. INTRODUCTION
 D-U-N-S® Number is D&B’s copyrighted
proprietary means identifying business entities
on a location specific basis.
Specific for each site.
Each distinct physical location of an entity (i.e.
branch, division and headquarter) would be
assigned a different D-U-N-S® Number.

10. FDA’s recommendation
 FDA will require D-U-N-S® Number for both the
facility and the registrant owner of the facility if both
are at different locations.
 D-U-N-S® Number is required to uniquely identify
registrant owner and each physical location of the
business entity of the registrant.
 D-U-N-S® Number serves as useful resource for
FDA in identifying and verifying certain business
information submitted by a user.

11. Number
Verification
and
existence of
operations
Demographic
information
Corporate
relationship
s
Compatibility
with National
Business
registries -
USFDA &
MHRA
Keep
accurate
business
data

12. What do I need to get my D-U-N-S®
Number
D-U-N-S
®
Number
Legal
Name
Head-
quarters
name
DBA or name
by which
business is
recognized
Address,
City, State
and ZIP
code E-mail
Address
Telephone
number
No. Of
employees
at physical
location

14. FEI number
 FEI number – a unique identifier designated by
FDA to assign, monitor and track inspections
of regulated firms.
F – Facility
E – Establishment
I – Identifier

15. FEI number
 FDA assigns only one FEI number to separate
buildings:
If they are in close proximity.
If the activities conducted in each building are
closely related to the same business enterprise,
Are under the supervision of same local
management
Are capable of being inspected by FDA during a
single inspection.

16. How to obtain FEI number
Generic drug facilities,
Sites & organizations
Previously registered
with FDA
Existing
FEI No.
Not Previously registered
with FDA
Application for new FEI
no.
Email request to FDA
GDUFA FEI Request
in the subject line
Provide subsequent
information

17. What do I need to get my FEI
Number
FEI
Number
Legal Name
Type of
operation :
Manufacturer ,
Labs etc
Address,
City, ZIP
code, State,
Country
E-mail
Address &
Telephone
number
Type of
Industry :
Drugs
Size of the
firm

18. Penalty for failing to Self identify
All FDF & API
manufactured
at the facility
will be
deemed
misbranded
It is a
violation of
Federal Law
to ship
misbranded
product in
interstate
commerce or
to import
them into
United States
Such
Violations are
responsible
for Seizures
of the
misbranded
product
Misbranded
product are
subjected to
being denied
entry into
United
States.