FEI Number: What the FDA Establishment Identifier Is

General information about a regulatory identifier, not legal or medical advice.

Short answer

An FEI number (FDA Establishment Identifier) is a unique identifier issued by the U.S. Food and Drug Administration to track inspections of a regulated establishment or facility. It is also used to track GDUFA facility fee payments. A firm does not choose it, and it is not an approval or a quality rating.

What an FEI number is

FDA’s own cover-sheet clarification for generic drug user fees defines the number in one sentence: it is “a unique identifier issued by FDA to track inspections of the regulated establishment or facility,” and FEI numbers are also used to track GDUFA facility fee payments. The same page says the FEI is different from a Central File Number and from a Federal Tax Identification Number, and that the Central File Number is no longer used for inspection purposes (FDA page marked current as of 11/30/2015; checked 2026-10-30).

FDA’s animal food registration FAQ describes the FEI as a separate, unique public identifier that can be looked up through FDA’s FEI Search Portal (page current as of 10/28/2026; checked 2026-10-30). “FEI” here means the FDA identifier only. It is unrelated to a company’s tax number and to the international equestrian federation that shares the abbreviation.

FEI vs DUNS number vs FDA registration number

Vendor paperwork and FDA forms use several look-alike numbers. The rows below draw on the FDA pages listed under Sources.

Identifier	Who issues it	What it is for, per FDA
FEI number	FDA	Tracks inspections of a regulated establishment; also tracks GDUFA facility fee payments. Public and searchable through the FEI Search Portal.
DUNS number	Dun & Bradstreet	Each business entity gets a distinct site-specific 9-digit number. Required for foreign organizations to register in FDA’s User Fee System. FDA recognizes it as an acceptable unique facility identifier (UFI) for food facility registration.
Food facility registration number	FDA, on registration	An assigned registration number only confirms registration; it does not imply FDA approval or endorsement.
Central File Number	FDA (legacy)	Different from the FEI and no longer used for inspection purposes.
Federal Tax Identification Number	Not FDA	Different from the FEI, according to FDA’s clarification page.

DUNS number and FDA

Dun & Bradstreet assigns and maintains DUNS numbers; FDA does not. Under 21 CFR 1.232(a)(2), food facility registration information must include, beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA. The regulation text names neither DUNS nor FEI. FDA’s FAQ states that FDA recognizes the DUNS number as an acceptable UFI to date. The FEI is a separate identifier, so a DUNS number cannot stand in for it.

FDA registration number and FDA establishment identifier

“FDA registration number” and “FDA establishment identifier” are often used as if they were the same thing. FDA’s FAQ treats the FEI as separate from the assigned registration number. FDA’s registration and listing database lets you search by “Registration or FEI Number” in one field, which is why the two are easy to blur. See how to read an FDA registration and listing record.

Where an FEI number appears in practice

Because the FEI exists to track inspections, it is the key that links a site to its inspection history. The inspection search accepts an FEI; the walkthrough is in the FDA inspection database guide. For food sites, registration rules are covered in FDA food facility registration. Device identifiers on labels are a different system, described in UDI labeling and GUDID submission, and a federal-award identifier is another again: the SAM.gov Unique Entity Identifier.

A checklist for a vendor’s number

1. Identify which number it is. A 9-digit site-specific DUNS number, an FEI and a registration number are three different things; ask which one the document shows.
2. Look the FEI up through FDA’s FEI Search Portal, which FDA describes as the public lookup, rather than relying on a quoted number.
3. Treat a match as confirming that the identifier exists. FDA states a registration number only confirms registration, without implying approval or endorsement.
4. Do not substitute a tax number or a Central File Number; FDA says both differ from the FEI.
5. For a question about an assigned number, FDA’s clarification page directs domestic firms to the FDA district office and foreign firms to the FDA GDUFA FEI request mailbox named on that page.

Common misunderstandings

• “An FEI means FDA approved the site.” The FEI is an identifier for tracking inspections and fees. FDA says a registration number likewise implies no approval or endorsement.
• “FEI and FEIN are the same.” FDA’s page says the FEI differs from a Federal Tax Identification Number.
• “We apply for an FEI.” FDA issues it; it is described as an identifier issued by FDA.
• “DUNS replaces FEI.” They are issued by different bodies for different purposes.

FAQ

What is a DUNS number for FDA?

A 9-digit, site-specific number assigned by Dun & Bradstreet. FDA requires it for foreign organizations registering in the User Fee System and recognizes it as an acceptable UFI for food facility registration.

What is an FDA registration number?

The number assigned when a facility registers. FDA says it simply confirms registration without implying approval or endorsement. It is separate from the FEI.

What is an FDA establishment identifier?

Another name for the FEI: a unique identifier issued by FDA to track inspections of a regulated establishment or facility.

Sources

• FDA, GDUFA Cover Sheet Clarifications – Facility (content current as of 11/30/2015; checked 2026-10-30).
• FDA, Animal Food Facility Registration and Qualified Facility Attestation FAQ (content current as of 10/28/2026; checked 2026-10-30).
• Legal Information Institute, 21 CFR 1.232 (checked 2026-10-30).