The U.S. Food and Drug Administration (FDA) requires facilities that manufacture, process, pack, or store food for U.S. consumption to renew their FDA registrations between October 1 and December 31, 2018. During the renewal process, facilities located outside of the U.S. must also designate a U.S. Agent for FDA communications. The renewal will not be considered complete until the listed U.S. Agent accepts this designation.
It should be noted that renewing a registration is distinct from updating a registration, and even food facilities that registered with FDA as recently as September 2018 will be required to renew. Facilities should ensure they properly renew during this period so their FDA registrations remain valid for 2019.
What are the Consequences of Not Renewing?
FDA will cancel facility registrations that are not properly renewed during the impending Biennial Registration Renewal period. Failure to renew FDA registrations during the 2016 renewal period contributed to a 28% drop in the number of registered food facilities in early 2017.
Food exported to the U.S. by a facility with a canceled registration may be detained or refused at the U.S. port of entry. Any facility that markets food for consumption in the U.S. without a valid registration may also be subject to civil or criminal penalties.
Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can properly renew your registration and can act as the U.S. Agent for facilities outside the United States. As part of our registration renewal service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more.
To learn more, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.