FDA Registration Renewals: FDA Increases Facility Enforcement

FDA Registration Renewals: FDA Increases Facility Enforcement

FDA Registration RenewalAs a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal registration. The process of registering your facility with the FDA can be confusing, but it’s essential to comply in order to avoid penalties or even shutting down your operation.

Introduction:

The American Food and Drug Administration (FDA) is stepping up action against food facilities that failed to renew their FDA registration for 2023 and those that failed to include a DUNS number in their registration renewal.

Facilities with invalid registrations are actively being removed from FDA databases, essentially having their registrations cancelled. FDA-regulated goods that are imported into the country without a current register will be held there.

To prevent pricey detentions and delays, businesses should renew their registrations as soon as possible. You can continue selling your goods in the US as soon as you act. 

Our regulatory specialists can help you renew your FDA registrations if you’re a manufacturer of; dietary supplements, medical devices, OTC drugs or food and beverages in the United States.

When was the FDA Facility Registration Renewal Deadline?

All regulated goods’ FDA registrations had to be renewed by December 31, 2022, to be valid in 2023. The renewal period for drug and medical device businesses is from October 1 to December 31 each year. Every two years on even-numbered years, food establishments must renew their registration between October 1 and December 31.

The Food, Drug, and Cosmetic (FD&C) Act was updated by the FDA in 2016 to require food facilities to acquire a Unique Facility Identifier (UFI). (21 CFR 1). The only UFI that the FDA presently accepts is the DUNS number. 

Following several extensions, the FDA declared in 2021 that it would start enforcing the UFI rule in December 2022, during the registration renewal period.  The FDA starts cleaning up its inventory of businesses that did not renew at the beginning of every year resulting in many registrations having become invalid if renewal didn’t occur.

What is FDA Renewal Registration?

The FDA renewal registration is a process that all food, drug, medical device, and cosmetic facilities are required to complete in order to comply with regulatory requirements. This registration must be renewed every other year between October 1st and December 31st of even-numbered years. It serves as a way for the FDA to collect updated information about facilities and ensure that they are following regulations related to product safety and quality. Failure to complete the renewal registration could result in penalties or the suspension of your facility’s operations.

How to renew your FDA Registration? 

Your registration renewal must be correctly submitted and include all necessary details. Renewing your license may be necessary based on how your products are governed: Food establishments had to update in 2023 and include their DUNS number.  For each food facility owned by a business, a unique DUNS number is required. Registrations for food facilities that are filed without a current DUNS number are invalid and may be canceled.  

For all product listings that have not been updated during the current year, drug establishments are required to list all available products, designate a Registrant Contact, and send a “Blanket No Change Notification”. Section 510 of the Federal Food, Drug, and Cosmetic Act mandates that drug registration and listing data be provided electronically in the structured product labeling (SPL) format.

Medical device businesses are required to identify their equipment and describe the procedures carried out on it. Companies must also appoint an Official Correspondent who oversees filing. The submitter must include the premarket application number (510(k), De Novo, PMA, PDP, HDE) if a premarket submission is necessary for the device. (21 CFR Part 807). Companies based abroad are required to name a U.S. Agent for FDA communications for all sectors.

What happens if you didn’t renew your FDA Registration?

You cannot legitimately market your goods in the United States if your registration has not been renewed.  Products that are shipped to the United States without a valid registration are susceptible to detention and are probably going to be stopped by U.S. Customs Border Protection. (CBP). Until you present a legitimate registration number, CBP will continue to hold your shipment, causing expensive delays.

Every day CBP keeps your shipment on hold, you’ll pay fees and lose possible revenue. Detentions are public information, so your brand’s image might also suffer because of importers favoring suppliers without Invalid facility licenses or detentions on record. 

How can you avoid FDA enforcement actions?

Thousands of registrations that were improperly renewed before December 31, 2022, were marked invalid by FDA.

Make sure your FDA license is current to avoid needless fines. If your registration is presently inactive, renew it as soon as you can, and take precautions to avoid having an invalid registration in the future. 

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