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 efficiently, 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.
If you manufacture, process, pack, or hold food for human or animal consumption in the U.S., you need to be familiar with some of the more pertinent details of the Food Safety Modernization Act. To help with
this, we’ve compiled a list of commonly asked questions.

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 Identifier (UFI) will be required to be submitted with the registration
information. FDA recognizes the Data Universal Numbering System D-U-N-S (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.

Need more information about the new registration or renewal process

Contact us at fda@smis-cert.com or call on 00923248841990