Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are registered with FDA to renew facility registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If a registration is not renewed by December 31, 2018, the registration is considered expired and will be removed by the FDA from the system and will require a new registration.
Under the 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 registrations. When registering, foreign food facilities must also designate a U.S. agent, a person or entity that is located or maintains an office in the U.S. and acts as the facility’s domestic representative 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 this confirmation.
For food facilities, failure to register can result in the facility being prohibited from importing or exporting food into or from the U.S., offering to import or export food into or from the U.S., or otherwise introducing food into interstate or intrastate commerce. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action.
In addition, owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make, and the activities performed on those devices at that establishment. Failure to submit, renew, update, or cancel a registration can also result in civil or criminal action.
RENEWAL BEGINNING OCTOBER 1, 2018 AND ENDING DECEMBER 31 2018