What Is an FEI Number and Why It Matters for Every FDA-Registered Facility

After a foreign food or drug facility completes its FDA registration, the FDA issues a confirmation that includes a seven-digit number known as the FEI — the FDA Establishment Identifier. The FEI number is the FDA's permanent identifier for that facility across the FDA's entire regulatory system. It does not change when the facility updates its registration information, when it renews its registration, or when it adds new product categories. The FEI is issued once and stays with the facility permanently. For foreign manufacturers, the FEI number is the primary identifier used in every subsequent interaction with the FDA's import and compliance systems.

Where the FEI number appears

The FEI number appears in multiple FDA systems and documents. In the FDA's facility registration database — searchable publicly at the FDA's website — the FEI is the primary search key for locating a specific registered facility. In Prior Notice submissions for food imports, the manufacturing facility must be identified by its FEI number. In FDA inspection records, the FEI links the inspection report to the registered facility. In drug establishment registration, the FEI connects the registration record to the facility's drug listing and labeler code. In the FDA's import system, CBP uses the FEI to verify that a food or drug shipment is coming from a currently registered facility before the shipment is released.

The FEI is different from the DUNS number

A common point of confusion is the relationship between the DUNS number and the FEI number. The DUNS number is a commercial identifier issued by Dun & Bradstreet that the FDA uses as a prerequisite for food facility registration submissions — it is required to start the registration, but it does not come from the FDA. The FEI number is issued by the FDA after the registration is processed and confirmed. Once the FEI is issued, the FEI becomes the FDA's internal identifier for the facility going forward. The DUNS remains on the registration record, but the FEI is what FDA personnel, customs officials, and compliance systems use to reference the facility in the US regulatory environment.

How to look up an FEI number

The FDA maintains a publicly searchable facility registration database that allows anyone to look up a facility's registration status using the FEI number, the facility name, the DUNS number, or the country of the facility. Foreign manufacturers can use this database to verify that their registration is currently active and that the information on file matches their current details. US importers and distributors routinely use this database to verify that a foreign manufacturer's facility is registered before agreeing to import products from that facility. A facility that is not found in the database, or that appears in the database with an inactive registration status, cannot legally have products imported into the United States until the registration status is corrected.

What happens when an FEI is associated with a lapsed registration

The FEI number itself does not expire, but the registration associated with it can lapse if the annual or biennial renewal is missed. When a registration lapses, the FEI remains in the FDA's system but the registration status changes to inactive. Products from a facility with an inactive registration status are subject to refusal at the US border. Restoring an inactive registration requires re-submitting the registration through the FDA's FURLS system and waiting for the FDA to process the renewal. During the period between lapse and restoration, shipments from the facility face significant import risk.

How FDABridge monitors FEI and registration status

FDABridge tracks FEI numbers and registration status for all client facilities on an ongoing basis. We monitor the FDA database for status changes, alert clients to upcoming renewal deadlines, and manage the renewal submissions before registration lapses. Visit fdabridge.com/food to learn about our registration maintenance services or fdabridge.com/apply to get started.