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FEI

FDA Establishment Identifier

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FDA Establishment Identifier (FEI)

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration.

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA, and list all of their commercially marketed drug products.

Having an FEI Number and DUNS Number will facilitate the application process and establishment registration.

Section 510 of the Food, Drug, and Cosmetic Act requires that each initial and annual drug establishment registration include a Unique Facility Identifier (UFI).

FDA’s preferred UFI for a drug, medical device or cosmetic establishment as well as food facility, is the DUNS Number, assigned and managed by Dun & Bradstreet Inc.

FDA recommends that at the time of registration, the owner or operator obtain an FEI Number. Firm Establishment Identifier (FEI) should be used for identification of entities within the imports message set.

An FDA Establishment Identification (FEI) number is a unique identifier issued by the FDA to track inspections of regulated establishments or facilities. FEI numbers are also used to track User Fees payments.

Please note that an FEI Number is different from an Employer Identification Number (EIN) also known as a Federal Tax Identification Number used to identify a business entity.

FDA U.S. Agent

The Facility FEI (FDA Establishment Identifier) Number data element is a number assigned by the FDA and can be requested at no cost.

IMPORT ENTRIES

The Food and Drug Administration (FDA) reminds the import community to utilize helpful tools, available at no cost to users, so complete and accurate information can be submitted to FDA in order to facilitate efficient processing of import entries.

FEI PORTAL

It allows the import community look-up and verify an entity’s FEI.

FEI Portal assists users in identifying:

  • FEI numbers associated with a specific address
  • Address associated with a FEI number for a firm already in FDA’s firm inventory.

Users can sign up for an account, access the FEI Portal and log in by visiting:

FDA REGISTRATION

You may want to consider the following service, should you be ready to start the registration of your domestic or foreign company.

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