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FDA Invalidating Food Facility Registrations for Failure to Complete Renewal Process

Wednesday, February 15, 2017
Sandler, Travis & Rosenberg Trade Report

Under section 102 of the Food Safety Modernization Act, all domestic and foreign facilities that manufacture, process, pack, or store food, food ingredients, pet foods, or dietary supplements are required to renew their registration with the Food and Drug Administration every even-numbered year. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located within, or maintains an office in, the United States and acts as the domestic representative for the foreign facility through which all communication with the FDA takes place. U.S. agents must confirm that they have agreed to serve as such and the FDA will not confirm a registration or provide a registration number until the U.S. agent has provided such confirmation.

According to a U.S. Customs and Border Protection administrative message, the FDA has invalidated food facility registrations that were not renewed by Dec. 31, 2016, or for which the U.S. agent was not designated or did not confirm such designation. CBP states that any filers receiving an entry rejection for an invalid registration will need to confirm the status of the registration with the manufacturer, which may check the status of its registration by logging into its FURLS Food Facility Registration Module account.

CBP states that registrations that have been invalidated cannot be renewed and a new registration must be created. In addition, the U.S. agent or the owner must confirm the receipt of the new registration within 30 days for it to be valid in the FDA reference database. Failure to have a valid registered manufacturer can cause a shipment delay greater than 24 hours; as a result, CBP does not recommend filing a prior notice if the registration is pending or using an invalidated facility registration.

Sandler, Travis & Rosenberg's FDA Practice Group offers food facility registration services as well as service as a U.S. agent for foreign facilities. To learn more, please contact Shelly Garg at (305) 894-1043.

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