FEI Number: FDA Establishment Identifier and How It Differs From DUNS

An FEI number is the FDA Establishment Identifier. FDA's own statute text defines it as "the unique number automatically generated by Food and Drug Administration's Field Accomplishments and Compliance Tracking System (FACTS)" (21 U.S.C. 379j-71(4)). FDA uses it to track inspections of the establishments it regulates. Some FDA documents write it as Facility Establishment Identifier. It is the same number.

A company does not choose its FEI. FDA assigns one to each site, and the number then follows that site through inspections, applications and enforcement records.

What the number identifies

FDA's Q&A guidance on identifying manufacturing establishments in applications (October 2019) says "An FEI number is a facility specific identifier." FDA gives separate FEIs to sites that are not one business under one local management, or that it cannot inspect in a single inspection. A company with plants in several places holds several FEIs. In FDA's inspection citation data, 590 of 12,800 firm names appear under more than one FEI, and one name holds 87.

The format is not fixed. FDA's SPL implementation guide says an FEI is 7 or 10 digits, and FDA's device guidance says it has issued 10-digit FEIs since 2000. In the inspection citation data (14,226 FEIs), 11,384 have 10 digits and 2,809 have 7. A few dozen are shorter. Keep the value as text, not a number, or you lose leading zeros.

FEI against the other identifiers

DUNS. A DUNS number is a commercial identifier from Dun & Bradstreet. FDA's GDUFA page says each business entity is assigned a distinct site-specific 9-digit DUNS number. FDA calls the DUNS number the preferred unique facility identifier (UFI) for drug establishments, under its November 2014 UFI guidance. The device system GUDID uses DUNS to identify the labeler, and 21 CFR 830 mentions neither DUNS nor FEI.

Registration numbers. For devices, 21 CFR 807.35(a) says FDA assigns each establishment a registration number. The device registration number and the FEI can be different numbers for the same site. FDA's device registration database searches both in one field, labeled "Registration or FEI Number". For drugs, the 2026 proposed rule describes the establishment registration number as the FEI.

What FDA requires, as of November 2026

• Drug establishment registration. 21 CFR 207.25(e) requires a unique facility identifier, and FDA recognizes DUNS for it. Section 207.25(d) asks for the registration number "if previously assigned by FDA". An FEI is not a condition of registering.
• Drug applications. Form FDA 356h has fields for "Registration (FEI) Number" and "Establishment DUNS Number" (edition 05/26). The 2019 Q&A guidance says the agency needs the FEI to proceed with the facility part of the application review. It also says not to delay an application because you lack one. It recommends a facility table in Module 3 with an FEI column.
• GDUFA. Facilities identify themselves with an FEI. The cover sheet asks for the facility's name, address, FEI and DUNS. FDA's paid facilities list has a Facility FEI column and warns that a wrong FEI may misapply a payment.
• Proposed rule. FDA's proposed rule on drug establishment registration and listing, published 13 July 2026 (91 FR 42888, comments closed 11 September 2026), says FDA does not propose to change the UFI numbering system or the FEI. It proposes a sub-FEI for distributed manufacturing units. It is a proposal and does not bind anyone.
• Devices. The device registration statute asks for establishment names and places of business and does not call for a UFI. We did not find an FDA statement that a DUNS number is required to register a device establishment. FDA does require DUNS numbers of foreign firms opening a MDUFA user fee account.
• Food. 21 CFR 1.232(a)(2) requires a UFI that FDA recognizes, and FDA says DUNS is acceptable. FDA's reminder of 29 September 2026 says biennial renewal closes on 31 December 2026.
• Cosmetics. FDA's Form 5066 page says the facility registration number is the FEI.

We found no 2025 or 2026 FDA change that drops the FEI or DUNS requirement for any of these.

Where an FEI appears

• Form FDA 483. The header of the form has a box labeled FEI Number. The Investigations Operations Manual says establishment inspection reports created in FDA's eNSpect system should automatically include the firm name and FEI. See the entries on Form 483 responses and the establishment inspection report.
• Warning letters. Letters sometimes cite the FEI in their text. It is not a standard field.
• FDA Data Dashboard. Inspection, citation, import refusal and compliance action records carry an FEI field.
• Drug establishment data. FDA's DECRS download has columns for both FEI and DUNS numbers.
• Applications. NDA, ANDA and BLA facility sections list it, as above.
• Not in UDI. GUDID records name the labeler by DUNS, and the GUDID guidance does not mention the FEI.

Finding an FEI

1. FDA's Data Dashboard. Its Firm/Supplier Evaluation search accepts a firm name or an FEI number.
2. Our inspection search. It searches by firm name, not by FEI. Each inspection it lists shows the site's FEI and links to FDA's firm profile for that number.
3. FDA's FEI Search Portal. It is free and needs a login. FDA's FAQ, as reproduced on a mirror dated 2023, limits it to 50 searches an hour and says not every FEI is searchable.
4. FDA's databases. The device registration and listing database searches by registration or FEI number, and the DECRS download covers drug establishments.

If you have no FEI, FDA's guidance describes an email request. The 2019 Q&A guidance gives one address for GDUFA facilities and another for PDUFA and BsUFA facilities, and the portal's FAQ gives a third. These documents are dated 2019 to 2023, so take the current address from the portal, not from a guide.

Search by FEI on FDA's Data Dashboard when you have it. FDA's FAQ says an FEI may have changed even though a firm's name and address stayed the same, and FDA merges duplicate records into one surviving FEI. In the inspection citation data every FEI carries exactly one firm name, so inspections from before a rename sit under the same name as later ones. A search by an old name can miss them. About 36% of FEIs (5,103 of 14,226) appear on more than one inspection, which is how a site's history is traced. scripts/analyze-fei-numbers.py produces these counts.

FDA does not state that an FEI never changes. We found that claim only on vendor sites and left it out.