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FDA Issues Updated Q&A Document on Food Facility Registration

Tuesday, November 08, 2016
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has issued an updated guidance for industry with questions and answers on the food facility registration requirements. The draft guidance contains 15 sections of a multi-section document intended to provided updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act. Interested parties may submit comments on this document by Feb. 6, 2017.

As previously reported, food facilities required to register with the FDA must renew their registrations by Dec. 31. Food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted or renewed must be held at the port of entry for and may not be delivered to the importer, owner, or consignee until the foreign facility is registered. Failure to register or renew a registration can also expose facilities to civil or criminal action.

Facilities can register online, via mail, or by fax (though FDA encourages online registration) or may authorize third parties to register for them. Sandler, Travis & Rosenberg's FDA Practice Group offers food facility registration services, including identifying a company's registration obligations, potential exemptions, and registering a foreign or domestic company, as well as service as a U.S. agent for foreign facilities. To learn more about U.S. food regulatory compliance requirements and to ensure your company is registered during the renewal period this year, please contact Shelly Garg at (305) 894-1043.

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