FDA Establishment Identifier: The Transition from DUNS to FEI and What It Means for Foreign Facilities

Foreign manufacturers registering with the FDA must navigate a system of facility identifiers that can be confusing even for experienced regulatory professionals. The FDA currently uses several overlapping identification systems: the DUNS number (issued by Dun & Bradstreet), the FDA Establishment Identifier (FEI), and the Unique Facility Identifier (UFI). Each serves a different purpose within the FDA's registration infrastructure, and the relationships between them have evolved over time as the FDA has updated its information systems. Understanding which identifier is needed for which registration, how to obtain each one, and how they interact is essential for maintaining accurate and current FDA registrations.

What is an FEI number

The FDA Establishment Identifier (FEI) is a unique number assigned by the FDA to each establishment that the agency has regulatory interest in — including food facilities, drug establishments, device establishments, cosmetic facilities, and biologics facilities. The FEI is assigned by the FDA, not by the registrant — it is generated when the FDA creates a record for the establishment in its internal databases. An FEI may be assigned during the registration process, during an FDA inspection, or when the FDA receives information about a facility through import entries or other regulatory interactions. The FEI is used internally by the FDA to track all regulatory interactions with a specific establishment, including registrations, inspections, Warning Letters, import alerts, and enforcement actions.

The role of the DUNS number in FDA registration

The DUNS number — a nine-digit identifier issued by Dun & Bradstreet — serves as the Unique Facility Identifier (UFI) for FDA food facility registration and drug establishment registration. When a foreign manufacturer registers a food facility or drug establishment with the FDA, the DUNS number is required as part of the registration submission. The DUNS number must match the exact legal entity name and physical address of the facility being registered — any discrepancy between the DUNS record and the FDA registration will cause problems, ranging from registration processing delays to import holds when the data does not align across systems.

Unique Facility Identifier requirements

The FDA requires a Unique Facility Identifier (UFI) for drug establishment registration under 21 CFR Part 207 and for food facility registration under 21 CFR Part 1, Subpart H. The UFI is currently the DUNS number issued by Dun & Bradstreet. The FDA implemented the UFI requirement to create a standardized way to identify facilities across its various registration systems, reducing duplication and improving data quality. The UFI requirement means that each physical location that registers with the FDA must have its own DUNS number — a company with multiple manufacturing sites must obtain a separate DUNS number for each site, even if all sites are owned by the same legal entity.

How FEI and DUNS relate to each other

A single facility may have both an FEI number and a DUNS number. The FEI is assigned by the FDA and is the internal identifier the agency uses across all its systems. The DUNS number is obtained by the facility from Dun & Bradstreet and is submitted to the FDA as the UFI during registration. The FDA links the DUNS number to the FEI in its databases, so that information from the registration (which uses the DUNS) can be connected to information from inspections, import entries, and enforcement actions (which use the FEI). If the facility changes its DUNS number — for example, due to a change in legal entity name, merger, or address change — the FDA registration must be updated to reflect the new DUNS number, and the FDA will maintain the linkage between the old and new DUNS numbers in its records.

Common problems with facility identifiers

The most common problem foreign manufacturers encounter is a mismatch between the DUNS record and the FDA registration. This can occur when the facility's legal name is recorded differently in the DUNS system and the FDA system (a common issue for companies with names in non-Latin scripts that must be romanized), when the facility's address is formatted differently, or when the DUNS record has not been updated to reflect a name change, address change, or corporate restructuring. These mismatches can cause registration rejections, Prior Notice filing errors, and import holds. The fix requires updating the DUNS record first (which can take weeks), then updating the FDA registration to match.

How FDABridge manages facility identifiers

FDABridge handles DUNS number acquisition and FDA registration as an integrated process, ensuring that the facility information in the DUNS record and the FDA registration are consistent from the start. We also monitor for changes that might create mismatches — such as corporate name changes or address updates — and coordinate the necessary updates across both systems. Visit fdabridge.com to see our registration services or fdabridge.com/contact to discuss your facility identifier needs.