On February 1, 2017, the U.S. Food and Drug Administration (FDA) removed all food facility registrations that were not properly renewed for 2017 from its registration database. Under the Food Safety Modernization Act (FSMA), food facilities are required to renew their FDA registrations between October 1 and December 31 of each even-numbered year. FDA considers any registrations not renewed by the deadline to be expired and removes these registrations from its database. Once removed, registration numbers typically cannot be reinstated. Facilities with expired registrations will need to re-register with FDA and obtain a new registration number before they manufacture, process, pack, or store food, beverages, or dietary supplements to be consumed in the United States.
14% of food facilities registered with FDA were removed from FDA’s database after the 2014 renewal period. Registrar Corp Vice President David Lennarz predicts that the drop in registrations may be even greater this year due to new verification requirements implemented during the 2016 renewal period. Food facilities located outside of the United States are required to designate a U.S. Agent for FDA Communications in their registration renewal. Unlike in previous years, individuals or entities listed as U.S. Agents in 2016 were required confirm with FDA acceptance of their designation and corresponding responsibility.
Prior to this new verification step, a U.S. Agent could be designated in a foreign facility’s renewal without the U.S. Agent’s affirmative written agreement. Many persons previously designated as U.S. Agents would have preferred to decline because a foreign facility’s U.S. Agent is liable for financial obligations, including payment of any FDA re-inspection fees related to the facility. The re-inspection fee rate for foreign facilities for Fiscal Year 2017 is $285 per hour (81 FR 50525). FDA may bill for every aspect of a re-inspection, including time spent preparing and traveling, so the fees can quickly add up to thousands of dollars. FDA also contacts U.S. Agents regarding shipments, inspection scheduling, and other regulatory matters. These matters often require an immediate response.
In 2016, FDA addressed the issue by implementing the new verification procedures. The agency does not consider a facility’s 2016 renewal confirmed unless the designated U.S. Agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its U.S. Agent did not affirmatively agree, its registration will have been removed from FDA’s food facility registration database.
To avoid costly detentions or regulatory action, it’s prudent for all food facilities to verify that their FDA registrations were properly renewed for 2017 before continuing with business as usual. This is especially true for food facilities located outside the U.S. Registrar Corp will verify that your FDA food facility registration was properly renewed for 2017 at no cost. Facilities that need a U.S. Agent may retain Registrar Corp. Simply contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
This blog was originally published as a press release.