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What You Need to Know

EAS food facility registration clients will remember during the 2020 renewal period, the FDA had sent reminders of the requirement per 21 CFR 1.232(a)(2), of a unique facility identifier (UFI) for every location registered with the agency as a food facility. The UFI is company and site specific. As was announced, and remains the case, the FDA has recognized the Data Universal Numbering System (DUNS) as the acceptable form of UFI. DUNS numbers can be obtained for free from Dun & Bradstreet. Assignment of a DUNS number can typically take 30 or more days. If you require your assignment more urgently, a one-time fee will be assessed by Dun & Bradstreet for this expedited service. Foreign facilities can find their country’s Dun & Bradstreet authorized representative via this link. Do remember, a fee should not be assessed for standard service.

Per the March 2021 issued Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period, the FDA extended the deadline for obtaining a DUNS number for food facility registrations until December 2022. The agency made ‘pending’ an available option for the UFI field of a food facility registration in the interim.

What Does This Mean for You?

The FDA fully expects all facilities to have had ample time to obtain a DUNS number over the past 2 years. For new facilities, the ‘pending’ option is available through 31 December 2022. Companies should allow for a 30-day period to obtain a DUNS number from Dun & Bradstreet. Per the guidance document: “Failure to update the registration with a valid DUNS number by the end of the next biennial registrational renewal cycle will result in cancellation of the registration for failure to renew in accordance with 21 CFR 1.230(b).”

Dun & Bradstreet can be contacted directly via https://www.dnb.com/duns-number/get-a-duns.html or by phone at 866-705-5711 for domestic companies. As previously noted, foreign entities can contact their local Dun & Bradstreet representative via https://www.dnb.com/choose-your-country.html.

You can also request support from your regulatory partner, EAS Consulting Group. Contact Victoria Pankovich at vpankovich@easconsultinggroup.com.

Posted in FDA Update.