The United States is one of the largest and most lucrative export markets for Indian manufacturers. However, entering this market requires strict compliance with US federal regulations. Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the US Food and Drug Administration (FDA) requires domestic and foreign facilities that manufacture, process, pack, or hold food, beverages, dietary supplements, or medical devices for consumption or use in the United States to register their facility. Exporting without a valid FDA registration leads to custom holds, delays, and product destruction at US ports.
Who Needs FDA Facility Registration?
You must register your facility with the FDA if you manufacture, pack, or hold items in any of the following categories:
- **Food and Beverages**: Spices, grains, tea, processed foods, snacks, canned goods, pet food, and animal feed.
- **Dietary Supplements**: Vitamins, minerals, herbal extracts, and protein powders.
- **Medical Devices**: Surgical instruments, laboratory tools, implants, diagnostics, and dental supplies.
- **Cosmetics & OTC Drugs**: Skincare products, personal care items, and over-the-counter medicines (which face additional listing rules).
The DUNS Number (Unique Facility Identifier) Requirement
The FDA requires all registering facilities to provide a valid Unique Facility Identifier (UFI). Currently, the FDA recognizes the DUNS (Data Universal Numbering System) number, issued by Dun & Bradstreet, as the only acceptable UFI. Before starting your FDA registration, your business must secure a DUNS number that exactly matches your legal name, physical address, and contact details. Any mismatch between your DUNS profile and FDA registration will result in the immediate rejection of your application. We will help you obtain and verify your DUNS number to prevent registration delays.
Appointing a US Agent (Mandatory for Foreign Exporters)
If your facility is located outside the United States, you must appoint a US Agent during your registration. The US Agent must have a physical address and phone number in the United States and be available during regular business hours. This agent serves as the official point of contact between the FDA and your foreign facility. The FDA uses the US Agent to schedule facility inspections, send emergency notifications, and discuss regulatory queries. Note that your US Agent is not responsible for sales, marketing, or customs clearing—they handle regulatory communication. We provide reliable, professional US Agent services to keep your compliance active.
Prior Notice of Food Shipments
Once your facility is registered and you are ready to export food products, you must file a Prior Notice with the FDA for every shipment. Prior Notice must be submitted before the food arrives at the US port of entry. It provides the FDA with details about the product, country of origin, manufacturer, shipper, and carrier. This allows the FDA to evaluate the shipment for safety risks before arrival. Failing to file a Prior Notice will cause customs to seize your shipment.
Biennial Registration Renewal Window
FDA food facility registrations do not last forever. You must renew your registration between October 1 and December 31 of every even-numbered year (e.g., 2026, 2028, etc.), regardless of when you first registered. If you fail to renew within this window, the FDA will deactivate your registration. Exporting on a deactivated registration is a federal violation. Our compliance team handles initial registration, DUNS mapping, US Agent representation, and timely biennial renewals so your export business runs smoothly.