FDA Food Facility Registration Renewal Period!!

Next week, on October 1, 2018, the FDA’s Biennial Registration Renewal Period begins for 2018.  Food facilities are required to register with the FDA and renew their registrations between October 1 and December 31 every year as specified under section 415 of the FD&C Act.

Food facilities that were registered or who’s listings were updated before October 1, 2018 must renew and update their registration before December 31, 2018.  The owner, operator, agent, or authorized party in charge of the facility can submit a facility registration renewal electronically using a FURLS account.  If your company wishes to submit your registration renewal via mail [U.S. Food and Drug Administration, Food Facility Registration (HFS-681), 5001 Campus Drive, College Park, MD 20740] or fax (301-436-2804), you must fill out and submit FDA Form 3537.  Facilities that do not have any information changes under 21 CFR 1.232 since the submission of their previous registration or renewal are able to go through an abbreviated renewal process.

The renewal process repeats every two years on even-numbered years from October 1^st through December 31^st.  From January 4, 2020 and onward, you must submit your registration, registration renewals, updates, and cancellations to the FDA electronically unless the FDA has granted a waiver from such requirement.

We at mdi can assist with any of your registration, listings and registration renewal needs. 

? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form. RE: Food Facility Registration.

If you require any additional assistance: mock FDA audits, 483 and Warning Letter responses and/or mediation, we can be of assistance.