Facilities that are situated outside the United States that manufacture, process, pack, or store food, beverages, or dietary supplements that are to be consumed in the United States are required to be registered with the U.S. Food and Drug Administration (FDA). Such facilities require the appointment of a US Agent for communication with the FDA.
Facility handling any of the food products mentioned below shall be registered:
Steps for FDA Food Facility Registration:
Details of the Sections of the Registration Form:
FDA Food Facility Registration Renewal:
It is required for the facilities to renew their registrations every other year during the period from 1st October to December 31st of each even-numbered year.
This is mandatory as per Section 415 (a) (3).
Authorized food facilities can renew their FDA Food Facility Registration electronically through FURLS Food Facility Registration Module (FFRM).
In case the facility fails to renew the registration, the registration is considered to be expired. The FDA cancels the facility registrations.
You must register before your facility begins manufacturing/processing, packing, or holding operations.
The owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States.
No. There is no fee for registration or renewal.
No. Facilities that manufacture/process, pack, or hold food entering the United States solely for the purpose of exportation or trans-shipment to another country (i.e., none of the food is for consumption in the Unites States) are not required to register (see 21 CFR 1.225). The intent of the Food Facility Registration regulation is to identify facilities that manufacture/process, pack, or hold food for consumption in the United States. However, food entering the United States solely for future export is subject to the Prior Notice of Imported Food regulation (see 21 CFR part 1, subpart I).
FDA has established a U.S. Agent Voluntary Identification System (VIS) in conjunction with our food facility registration database, the Food Facility Registration Module (FFRM). The purpose of the VIS is to ensure the accuracy of U.S. agent information and enable U.S. agents to independently identify the facility or facilities for which the agent has agreed to serve. This guidance provides information for U.S. agents and foreign facilities importing food into the U.S. who choose to utilize the VIS.
Maven ProfservDecember 21st, 2023
Scope: The newly proposed MDCG guidelines are...Read More
Maven ProfservSeptember 26th, 2023
In the field of medical device manufacturing, risk...Read More