FDA FEI – What you need to know

What is an FDA FEI?

An FDA FEI is a ten-digit number also known as an FDA Establishment Identifier. The number issued by FDA for purposes of tracking business locations subject to FDA regulations. FEI numbers are issued to food, drug, dietary supplement, medical device and biologics establishments, for example.

How do I find my FDA FEI number?

You can lookup your FEI number at the portal here. Registration is required. You can find some (but not all) FEI numbers may be found at the FDA data dashboard here.

How do I get an FEI number?

FEI numbers are issued to locations by FDA when they become aware that activities at those locations are subject to FDA regulation. For example, actions industry would take which would trigger an FEI number to be assigned include registering a food facility and being named on a customs entry as an importer for FDA-regulated products.

Is an FEI number the same as an FDA food facility registration number?

No. A food facility registration number is assigned when a facility registers through the FDA food facility registration portal (available here). You must submit a food facility registration number to FDA for shipments of food exported (e.g. Prior Notice) to the U.S. among other things.

How does an FEI differ from a UFI or DUNS number?

UFI stands for uniform facility identifier. Currently, the only number recognized by FDA as a UFI is a DUNS number. In other words, a DUNS number is a UFI. You must have a DUNS number/UFI to register a food facility with FDA and receive a food facility registration number. For more information on DUNS numbers click here.

FDA issued several FEIs to one of our locations. Can we request that they fix the issue?

Yes, you can request that FDA consolidate multiple FEIs under a single location. You can submit a request at feiportal@fda.hhs.gov.