FDA Food Facility Biennial Registration | New DUNS Requirement

The Food and Drug Administration (FDA) requires all businesses that manufacture, process, pack or hold food for consumption in the United States to register with the agency. The FDA Food Facility Biennial registration period occurs every two years.   Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.

Beginning October 1, 2020, and in accordance with 21 CFR 1.232(a)(2), the facility’s Unique Facility Identifier (UFI) will now be required. FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI.

Please visit the FDA DUNS Portal in order to obtain or verify your DUNS number.

User guides and instructions regarding the DUNS portal can be found here.  For assistance, we encourage users to create and log in to their account and initiate an inquiry from the portal.   For general DUNS inquiries, please email DUNSLookupSupport@dnb.com. If you have any questions regarding FDA’s Biennial Registration period, Livingston can help!  Please contact either your Livingston account manager or our regulatory affairs department at usregaffairs@livingstonintl.com