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FDA Food Facility Registrations Must Be Renewed Soon

It is October 1st and time to renew your food facility registration(s) with FDA.

Facilities (domestic and foreign) engaged in manufacturing, processing, packing, or holding food (human or animal) for consumption in the United States must register with FDA, unless exempt.  Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 350d) requires food facilities that are required to register with FDA to renew their registrations every two years, during the period beginning on October 1 and ending on December 31 of each even-numbered year.  Failure to comply with the registration requirement, including biennial renewal, is a prohibited act, subject to injunction and criminal prosecution.

This being an even-numbered year, you are required to renew your facility registrations starting today, and FDA is encouraging food facilities to renew early in the three-month renewal period.

As you may recall, in 2012, some facilities that did not renew their registrations in a timely manner found that FDA had invalidated their registrations and needed to obtain new registrations and new registration numbers.  In addition, some foreign facilities that did not renew their registrations had their shipments stopped at the port.  To avoid those headaches, we suggest renewing your FDA registrations while the subject is fresh in your mind.

While you’re at it, be sure to update any registration information that may have changed.  You are required to update any required registration information (e.g., the name, address, and phone number of the owner, operator, or agent in charge of the facility; an emergency contact phone number) within 60 calendar days after a change in that information.  You may also want to consider requesting proof of registration renewal from your suppliers.

To renew a registration of a food facility during the applicable time period, go to Registration of Food Facilities.  For additional information about facility registration, see:

•    Registration under FSMA;
•    Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide (Dec. 2012);
•    Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) (Dec. 2012)
•    Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (Oct. 2012); and
•    FDA Issues Final Compliance Policy Guide on Food Facility Registration (June 2014).

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