The U.S. Food and Drug Administration (FDA) requires all facilities that manufacture, process, pack, or store food for U.S. consumption to renew their facility registrations between October 1st and December 31st, 2020. This includes facilities that registered this year. Even if a facility registers as late as September 30th, 2020, they will still be required to renew that registration.
It is important to note that facilities located outside of the U.S. must also designate a U.S. Agent to communicate with the FDA on their behalf. FDA will not finalize a facility’s renewal until the U.S. Agent accepts the designation.
New this year, both U.S. and non-U.S. facilities will need to submit Unique Facility Identifiers (UFIs) as part of their renewal. If your facility does not already have a UFI, it is prudent to request one immediately. It is possible that this new requirement will cause a backlog of UFI requests. A delay in receiving your UFI puts you at risk of not being able to renew your facility in time.
Consequences of Missed Renewal
Failure to renew a facility registration during the biennial renewal period could result in the cancellation of the registration. As a result of facilities failing to renew in 2018, FDA removed 20% of food facilities from their registered database in early 2019.
Exporting food to the U.S. that was manufactured or processed by a facility that does not renew its registration may result in detention or refusal of the goods. Facilities within the United States that continue to produce food for U.S. consumption without a valid registration may be subject to civil or criminal penalties.
Renew with Registrar Corp
Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can help food facilities properly renew their FDA registrations. Our trained Regulatory Specialists take the stress out of the renewal process. We aid facilities in obtaining their UFIs and act as the U.S. Agent for facilities outside of the United States. As part of our registration renewal service, companies receive year-round regulatory support, including free prior notice filings, FDA compliance monitoring of their facility, detention assistance, and more.
For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.
