Who should register: Any domestic or foreign facility that manufactures, processes, packs, labels, stores, or holds food, beverages, animal food, or dietary supplements intended for consumption in the United States.
Governing Authority: FDA Food Facility is governed by 21 CFR 1.225–1.243, under the Bioterrorism Act of 2002 & FSMA of 2011.
Submission Method: Registration is submitted electronically through the FDA Unified Registration and Listing System (FURLS).
Foreign Facility Requirement: Foreign food facilities are required to appoint a U.S. Agent with a physical (non-PO Box) address in the United States.
Registration Outcome: Upon successful registration, the FDA issues a Food Facility Registration Number (FFR Number/11-digit ID), which is required for Prior Notice submissions and import documentation.
Biennial Renewal: FDA Food Facility Registrations must be renewed every two years during the official renewal period of October 1 through December 31 of each even-numbered year to maintain active status.
Eligibility Requirements: Facilities must provide complete business information, product details, and a valid Unique Facility Identifier (UFI), typically a DUNS Number issued by Dun & Bradstreet — required on every registration and renewal.
Comprehensive Support: Our end-to-end service includes registration preparation, UFI verification, electronic filing, renewal management, compliance consultation, and U.S. Agent representation for foreign facilities.
Consequences of Non-Compliance: Failure to maintain an active FDA Food Facility Registration may result in import refusals, detention without physical examination (DWPE), FDA warning letters, regulatory enforcement actions, shipment delays, and marketplace restrictions that can significantly impact business operations in the United States.
