FDA Food Facility Registration: A Step-by-Step Guide

October 19, 20266 min read

Foreign facilities that manufacture, process, pack or hold food for consumption in the US must register with the FDA, with limited exemptions (21 CFR 1.225). The process consists of the following steps.

1. Check Whether You Are Required to Register

If the food undergoes further processing at another foreign facility before it reaches the US, the registration requirement passes to that facility. However, if the second facility performs only minor activities such as labeling, the first facility is not exempt from registration. Farms, retail food establishments and restaurants are among the operations exempt from registration (21 CFR 1.226).

2. Obtain Your DUNS Number

Since October 1, 2020, a registration must include a unique facility identifier (UFI) recognized by the FDA (21 CFR 1.232). The FDA recognizes the DUNS number issued by Dun & Bradstreet as the UFI; the number is obtained free of charge (FDA, Food Facility Registration Q&A).

3. Designate a US Agent

A foreign facility provides the name, address, phone number and email address of a US Agent in its registration. The US Agent must reside or maintain a place of business in the US; a mailbox, answering machine or answering service cannot serve as the US Agent (21 CFR 1.227, 1.232).

4. Submit the Registration

Registration is completed before the facility begins shipping food to the US (21 CFR 1.230). The FDA does not charge a fee for registration (21 CFR 1.231). On completion, the FDA assigns a facility registration number; it does not issue a certificate and does not recognize "registration certificates" issued by private companies (FDA).

5. Do Not Miss the Renewal

Registration is renewed every two years, between October 1 and December 31 of each even-numbered year (21 CFR 1.230). The registration is also updated whenever facility information changes.

After Registration

Registration alone is not enough. A Prior Notice is filed for every shipment, and your US importer fulfills its FSVP obligation. Details of our registration service are on our service page.