Signed into law in 2011, the Food Safety Modernization Act (FSMA) expanded the preexisting U.S. Food and Drug Administration (FDA) registration requirements to include biennial registration renewals. Food facilities must now renew their FDA registration between October 1 and December 31 of each even numbered year. Registrar Corp put together the need-to-know facts about registration renewal.
Who is required to renew?
Domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. This does not include farms, restaurants, or retail food establishments.
What are the consequences for not renewing?
Failing to register, renew registration, or update required elements of a registration is a prohibited act. The federal government can bring a civil or criminal action in Federal court to prosecute a person who commits a prohibited act.
For foreign facilities in particular, any food shipped to the U.S. by a facility with expired registration will be held at its port of entry by FDA or sent to a secure facility by FDA or the Customs and Border Protection Service. FDA will restrict the food from being delivered to the importer, owner, or consignee until the responsible facility is properly registered.
Registering with FDA gives the agency permission to inspect a facility.
FSMA requires FDA to double the number of inspections it conducts every year through 2016. During an inspection, FDA will verify the facility’s registration status, check for labeling compliance and good manufacturing practices, and more. Registrar Corp offers a Mock Inspection Service for food facilities. The firm will dispatch a food safety expert trained in FDA inspections to help the facility prepare.
For foreign facilities, FDA will contact both the facility and its U.S. Agent about inspections. It’s good to be aware that since FDA updated its food facility registration system in August 2014, food facilities are no longer able to list the same e-mail address for both the facility and its U.S. Agent. Any facility that currently lists the same e-mail for both will be required to change this before it submits its renewal. Registrar Corp offers a U.S. Agent service that includes registration renewal. Also, facilities that choose to designate Registrar Corp as their U.S. Agent receive the mock inspection service mentioned above for no additional cost, other than travel and lodging expenses, if FDA sets an inspection date.
How do I renew my FDA registration?
You can renew your registration with FDA by mail, fax, or online, but a number of mistakes are commonly made when facilities attempt the renewal process on their own. Registrar Corp helps food facilities comply with FDA regulations and has successfully registered thousands of food facilities with FDA. As an added benefit of registering through Registrar Corp, you will receive a Certificate of Registration to display at your facility and assure clients of your FDA registration.
For any questions about FDA food facility regulations, or to learn more about Registrar Corp’s registration and U.S. Agent services, contact +1-757-224-0177 or get help 24 hours a day through the Live Help chat service: https://www.registrarcorp.com/livehelp.