FEI Number


Requesting an FEI Number
  • District Monitors (FDA Inspectors) assign FEI numbers. Once DRLS had all its questions answered, they should send on the request to the DM.

  • The DRLS group may ask you to submit a Labeler Code Request. A Labeler Code Request is not required for the assignment of an FEI number.


This text may be useful in an e-mail response to DRLS:

Company X is an international site that will not distribute finished product in the USA Market.We believe that we are following proper procedures according to FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing and advice previously provided by DRLS.Therefore, a Labeler Code is not required and a request will not be submitted for the facility.

[remember to replace Company X with the API manufacturer! ]

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf
  • Request an email notification of the FEI. However, you may need to keep asking if the number has been assigned, in case DRLS doesn’t remember to e-mail.

[updated 07-Jun-2010]
E-mail is likely to look something like this:

...
This is an official email from FDA electronic Drug Registration and Listing Team to inform you that the district office has assigned the following number ########## to your firm FIRM Name located at Firm Address as your firm's FDA Establishment Identifier (FEI) number per your request. The FEI number, also referred to as registration number is assigned to firms that are required to register (Refer to regulation 21 CFR, Part 207) and is site specific. ( i.e. Each drug establishment is assigned its own unique number.) Please revise your registration SPL to include this number and resubmit your registration electronically. This will assure your FEI number appear on our Drug Firm Annual Registration Site which gets updated directly by registration SPLs.
After the initial registration, all drug establishments are required to re-register annually on or before December 31st of each year, as required by section 510 of the Act. Also any changes in individual ownership, corporate or partnership structure, location or drug-handling activity shall be updated electronically.
For information on how to use the new electronic system please visit: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm177328.htm.
Regards,
DRLS Team

Drug Registration and Listing System (DRLS)/Center for Drug Evaluation and Research (CDER)/Food and Drug Administration (FDA)
Phone: 301-210-2840, Fax: 301-210-2849.
mailto:edrls@fda.hhs.gov


Once a sponsor receives an FEI number, he/she should update the Establishment Registration SPL and resubmit.This will then update the eList system and the Drug Firm Annual Registration Status website.The Drug Firm Annual Registration Status website is only updated once the sponsor resubmits the Establishment Registration electronically.

What if a Firm Does Not Have an FEI Number - Can Its Products Be Imported?
Yes, the firm is able to import the products while awaiting the FEI number assignment.
(e-mail from DRLS Team at FDA)


Adding an FEI Number to an Establishment Registration SPL

After you have received an FEI number, you must add it to your establishment registration SPL. Here is a guide:http://spl-work-group.wikispaces.com/file/view/ec_er_2_submitting_a_newly_assigned_fei_spl_r4_training_ecard.pdf



Once a sponsor receives an FEI number, he/she should update the Establishment Registration SPL and resubmit.This will then update the eList system and the Drug Firm Annual Registration Status website.The Drug Firm Annual Registration Status website is only updated once the sponsor resubmits the Establishment Registration electronically.