US FDA Food Facility Registration & US Agent Services

Understanding US FDA Food Facility Registration

Under Section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are legally required to register with the U.S. FDA.

Gitchia assists food, spice, rice, confectionery, and seafood exporters in obtaining official FDA registration numbers, securing U.S. Agent representation, and maintaining compliance with the Food Safety Modernization Act (FSMA).

Mandatory FDA Requirements for Exporters

• Biennial Registration Renewal: Registration must be renewed between October 1 and December 31 of each even-numbered year.
• DUNS Number Verification: U.S. FDA strictly validates facility physical address against Dun & Bradstreet (DUNS) records.
• US Agent Appointment: Foreign facilities must designate a permanent U.S. Agent physically residing in the United States.
• Prior Notice of Imported Food: Electronic notification to FDA before shipments arrive at U.S. ports of entry.
• FSMA Preventive Controls (HARPC): Implementing science-based Hazard Analysis and Risk-Based Preventive Controls.

Commercial Benefits for Exporters

• Uninhibited Entry into US Ports: Prevents refusal of admission, detention at border ports, and costly demurrage penalties.
• US Importer Confidence: American distributors and supermarket chains can verify your active registration on the FDA portal.
• Customs Clearance Acceleration: Seamless electronic clearance across US Customs and Border Protection (CBP).