2018 Food Facility Biennial Registration Renewal Required with new Updates

The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements to better protect public health by requiring additional registration information that will improve the accuracy of the food facility registration database for facilities both in the United States and abroad. This final rule will support the FDA’s efforts to act quickly in response to food-related emergencies and will help the FDA to use its inspectional resources more efficiently.

Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA. Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

In addition, the final rule adds certain new requirements that will improve the food facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are registered with FDA to renew facility registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If a registration is not renewed by December 31, 2018, the registration is considered expired and will be removed by the FDA from the system and will require a new registration.

All current Register-FDA customers will be renewed as part of our annual fee of $295.

If you would like to assign Register-FDA as your US Agent to renew your registration, please click here.

See for the number of registered facilities by activity, the following table.

 

Facility ActivityNo. Domestic FacilitiesNo. Foreign FacilitiesGrand Total
Grand Total 117601190418308019
Warehouse/Holding Facility (e.g. storage facilities, including storage tanks, grain elevators)5529645002100298
Manufacturer / Processor247676440889175
Repacker / Packer153163454649862
Labeler / Relabeler95172532634843
Acidified / Low Acid Food Processor288462799163
Animal Food Manufacturer / Processor511733478464
Commissary112712612388
Interstate Conveyance Caterer / Catering Point111312592372
Contract Sterilizer21419922206
Salvage Operator (Reconditioner)32316051928
Molluscan Shellfish Establishment54112241765
Other Activity Conducted138641695555