FDA UFI Enforcement: Why Your DUNS Number Can Make or Break Your US Market Access

Since September 2023, the FDA has been running automated verification checks on the Unique Facility Identifier — the DUNS number — submitted with every food facility registration. This is not a future initiative or a proposed rule. It is happening now, and facilities that fail verification are losing their registrations. For foreign food manufacturers who depend on the US market, understanding the UFI enforcement landscape is no longer optional. A single data error in your DUNS record can halt your exports.

What Is a UFI and Why Does the FDA Require It

The Unique Facility Identifier is a number that uniquely identifies each food facility registered with the FDA. Congress mandated the UFI requirement through the FDA Food Safety Modernization Act (FSMA) to strengthen the agency's ability to track, trace, and respond to food safety incidents. The FDA designated the Data Universal Numbering System (DUNS) number, issued by Dun & Bradstreet, as the acceptable UFI. Every domestic and foreign food facility that registers with the FDA must provide a valid, active DUNS number. Without it, your registration cannot be processed.

The Automated Verification System

Prior to September 2023, the FDA accepted DUNS numbers at face value during the registration process. Facilities could submit numbers without the agency cross-referencing them against the Dun & Bradstreet database. That changed when the FDA implemented an automated verification system that checks DUNS numbers in real time during registration and renewal. The system confirms that the DUNS number is active, that it corresponds to the correct legal entity, and that the physical address matches the facility being registered. If the system detects a mismatch, the registration is flagged.

What Happens When Verification Fails

When the FDA's system flags a DUNS number, the facility owner receives a notification with a 30-day window to correct the issue. Corrections may involve updating the DUNS record with Dun & Bradstreet, providing additional documentation to the FDA, or resolving discrepancies between the facility name and the DUNS record. If the facility fails to resolve the issue within 30 days, the FDA cancels the registration. A canceled registration means the facility's products cannot legally enter the United States.

Common Reasons for DUNS Verification Failure

Foreign manufacturers encounter DUNS verification problems for several predictable reasons. The most common is a name mismatch — the legal entity name in the DUNS record does not match the facility name submitted to the FDA. This often happens when companies use trade names, abbreviations, or translated versions of their legal name. Address discrepancies are another frequent cause, particularly for manufacturers in countries where address formatting conventions differ significantly from US standards. Expired or inactive DUNS numbers also trigger failures, especially for facilities that obtained their DUNS years ago and never updated the record.

The FDA Is Actively Canceling Registrations

This is not a theoretical risk. The FDA has been systematically reviewing existing registrations and canceling those with unacceptable DUNS numbers. Facilities that registered years ago with DUNS numbers that cannot be verified under the new system are receiving cancellation notices. The agency has made clear that maintaining a valid UFI is an ongoing obligation, not a one-time requirement at initial registration. Every biennial renewal cycle triggers a fresh verification check.

Impact on US Importers

The UFI enforcement wave affects US importers directly. Under FSVP regulations, importers must verify that their foreign suppliers are registered with the FDA. If a supplier's registration is canceled due to a DUNS issue, the importer cannot file Prior Notice for that supplier's products, and any shipments in transit may be refused at the port. Sophisticated importers are now requiring their foreign suppliers to provide proof of valid DUNS numbers as a condition of doing business.

How to Obtain or Update Your DUNS Number

Foreign manufacturers who do not yet have a DUNS number must apply through Dun & Bradstreet. The process typically takes 30 to 45 days for international applicants, though expedited processing is available for an additional fee. When applying, ensure that the legal entity name, physical address, and business classification match your FDA registration exactly. If you already have a DUNS number, verify that the record is active and that all data fields are current. Contact Dun & Bradstreet to request a copy of your record and make corrections before your next FDA renewal.

Steps to Protect Your Registration

First, log in to the FDA's registration system and confirm your current DUNS number. Second, contact Dun & Bradstreet and request a copy of your DUNS record. Third, compare every field — legal name, address, business status — between your FDA registration and your DUNS record. Fourth, resolve any discrepancies immediately. Fifth, set a calendar reminder to re-verify your DUNS record at least 60 days before each biennial renewal window. The cost of proactive verification is negligible compared to the cost of a canceled registration.

The 30-Day Correction Window Is Not Generous

Thirty days may sound reasonable, but for foreign manufacturers dealing with Dun & Bradstreet's international processing times, it is a tight window. Updating a DUNS record for a facility located outside the United States can take 30 days on its own. If you receive a verification failure notice from the FDA and your DUNS record needs updating, you may be racing against the clock. The only reliable strategy is to ensure your DUNS record is accurate before the FDA checks it.

FDABridge assists foreign food manufacturers with DUNS number acquisition, verification, and FDA registration management. We ensure your UFI data matches your registration before the FDA's automated system flags it. Visit fdabridge.com/food to learn about our registration services, or reach out at fdabridge.com/contact to discuss your facility's specific situation.