FDA Cancels Food Facility Registrations for Failure to Comply with UFI Requirement by Final Deadline

Apr 5, 2023 | FDA, Food, Law & Regulatory, Registration

During the 2020 biennial renewal period, FDA began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through third-party company Dun & Bradstreet. FDA extended this due date by an additional 90 days and eventually further extended it until December 31st, 2022. Following the institution of the UFI requirement, FDA allowed food facilities the option to enter the UFI as “Pending” on their registration while they awaited Dun & Bradstreet to assign the facility a DUNS number.

At the start of 2023, following the final deadline, FDA performed an internal UFI validation on each registration to identify discrepancies between information listed on the registration and information listed with Dun & Bradstreet. This validation process proved highly sensitive, with even minor inconsistencies causing validation failure. Frequently cited discrepancies included: facility name, facility address, incorrect DUNS number, or a “Pending” DUNS.  FDA sent notices to each facility, advising them to correct the inconsistencies for successful UFI validation and the continued validity of their registration. This notice allowed facilities an additional 60 days to rectify the issue. 

FDA has now begun notifying food facilities that have failed to comply within the timeframe provided in their notice that their registration has been canceled. They have advised that the registrations can be reinstated upon request after necessary corrections have been made.

FDA has also removed the option to enter a “Pending” UFI status. Companies cannot register a new food facility or renew an existing registration until the DUNS number has been assigned. 

Any facility that has received this email from FDA should take action to confirm that the information on their facility registration is consistent with what is listed in the Dun & Bradstreet database. Our team at FDAImports is experienced with filing FDA facility registrations as well as with troubleshooting problems that may arise in the process. Contact our team today if you require assistance with FDA facility registration.

This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.

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