FDA Food Facility Registrations
The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law in 2011 for the purpose of enabling the FDA to better protect public health by strengthening the food system. In order to improve the agency’s ability to respond to a food-related emergency quickly and e¨ciently, the FSMA requires that all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. register with the FDA. The Act
also requires biennial renewal of food facility registrations.
Who must register or renew registration?
Owners, operators, or agents in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. must register with the FDA, unless the facility is exempt under 21 CFR 1.226 from the requirements to register. If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf.
Why UFI (D-U-N-S) required for registration?
Beginning October 1, 2020, the facility’s Unique Facility Identi¦er (UFI) will be required to be submitted with the registration information. FDA recognizes the Data Universal Numbering System D-U-NS (DUNS) number as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet. FDA Portal in
order to obtain or verify your DUNS number.
