3 Consequences Of Failing To Renew FDA Registrations

By Sam Lewis

Under FSMA, U.S. manufacturers, processors, and packers of food — along with those facilities storing food — must renew FDA registrations every two years.

In years ending with an even number, facilities that manufacture, process, pack, or store food for animals or for humans must renew registrations with the FDA. This rule under FSMA is fairly new — the first renewal occurred in 2012 — so many facilities may not be completely familiar with requirements and consequences of not renewing. In those years ending with an even number, businesses performing the previously mentioned tasks must renew registrations with the FDA between Oct 1 and Dec 31. Included in these are facilities outside of the U.S. that ship food to be sold and consumed in the U.S.

Any non-renewed registration is considered expired by the FDA. If a company is found to be manufacturing, processing, packing, or storing food under an expired registration several different issues can occur, including:

1. Any food circulated in the U.S. with an invalid registration is unlawful. Should the government find your company performing tasks with an expired registration, civil or criminal actions in Federal court can be taken to arraign those committing forbidden acts.
2. Food products shipped to the U.S. with an invalid registration will be contained at its entry point. The food may be sent by the FDA or Customs and Border Protection to a secure facility. The food will not arrive to its final destination until the owner or importer of the product renews the facility’s registration.
3. According to FSMA, the FDA will be increasing the number of facility inspections it performs. Back in 2011, FSMA commanded the FDA to inspect all domestic, high-risk facilities before 2016. These inspections will occur every three years after that. All low-risk facilities in the U.S. need to be inspected by 2018 and every five years after. Additionally, FSMA required the FDA to inspect 600 facilities outside of the U.S. in 2011, and then multiply that number by two each year through 2016. During inspections, the FDA will review the inspected facility’s registration status. Non-registrations are a cause for a major violation during inspection.

How To Survive An FDA Audit

Fortunately, there are many options for food and beverage manufacturing, processing, packing, and storage facilities to renew registration with the FDA. Your company can renew its FDA registration online, through the mail or third-party consultant can be used.