The US FDA considers un-renewed food facility registrations by the final date as expired. Registrar Corp reports on the renewal requirement and the consequences of shipping to the US with an expired registration.
The US Food and Drug Administration (FDA) requires food facilities that ship food to the United States to renew their FDA registrations between 1 October and 31 December of every even numbered year. This is true for facilities located both inside and outside the United States. On its registration renewal webpage, the FDA states: ‘If a registration is not renewed by 11:59 PM on 31 December 2014, the registration is considered expired and will be removed from your account.’ It is a prohibited act to distribute food within the US with an expired FDA registration.If a foreign facility with an expired registration ships food to the US, FDA may hold the food at its port of entry until the facility is properly registered.
The registration renewal requirement was mandated by the FDA Food Safety Modernization Act (FSMA) in 2011, with the first-ever renewal period occurring in 2012. Because the requirement is fairly new, many facilities are unaware of it. The number of facilities registered with FDA in 2012 was cut in half by 2014, which was largely a result of facilities failing to renew their registrations during the 2012 renewal period. Often facilities do not realise their registration has expired until their products are detained at the U.S. border.
Unfortunately, there is no way to renew a registration after the renewal period ends. Any facility whose FDA registration has expired will need to complete an entirely new registration. When a foreign facility re-registers with FDA, it will need to list a US Agent for FDA communications. FDA expects the US Agent to be available 24/7 for contact regarding shipments and facility inspections, so it’s important to designate a reliable agent.
Registrar Corp, an FDA compliance firm, is knowledgeable on FDA regulations and acts as a reliable U.S. Agent for thousands of companies around the world. As a facility’s US Agent, it will biennially renew its registration and, in the case of a scheduled FDA inspection, will send a food safety expert to the facility to help it prepare for no additional cost other than travel and lodging expenses.
The firm has a representative in South Africa who offers assistance to all companies in Africa. It can assist facilities in determining whether or not their registration has expired. If it has expired, Registrar Corp can also properly register the facility with FDA.
If you would like assistance with FDA registration, contact Registrar Corp’s US office at 1-757-224-0177 or the South Africa office at +(27)21 979 5383. You can also receive live help from a regulatory advisor 24 hours a day at www.registrarcorp.com/livehelp.