US FDA & DUNS Number Registration

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US FDA Registration for Indian Exporters

The United States Food and Drug Administration – commonly known as the US FDA – is the federal agency responsible for regulating the safety and quality of food, pharmaceuticals, medical devices, cosmetics, and other consumer products sold or imported into the United States. Any Indian business that exports products falling under FDA jurisdiction must register with the US FDA before those products can legally enter American borders.

FDA registration is not a one-size-fits-all process. Different product categories have different registration requirements – and choosing the wrong registration type, or skipping the step entirely, results in shipment rejection at US customs, which is one of the most expensive and disruptive outcomes for an Indian exporter.

Types of US FDA Registrations

The FDA requires different registrations based on what your business manufactures or exports. Here is a clear breakdown of the four main categories:

Food Facility Registration (FFR)

Mandatory for all food manufacturers, processors, packers, and storage facilities that export food products to the United States. This registration is required under the Bioterrorism Act and must be renewed every two years during the October-December window. Every food exporter shipping to the US must hold a valid FFR – and must also submit a Prior Notice to the FDA at least 4 hours before the shipment arrives at a US port.

Drug Establishment Registration

Required for Indian pharmaceutical companies that export medicines, drug formulations, bulk drugs, or Active Pharmaceutical Ingredients (APIs) to the United States. Drug establishments must also list all their drug products with the FDA. This registration is renewed annually and is closely monitored – an unregistered or non-compliant drug exporter can be placed on the FDA Import Alert list, which effectively bars all shipments from that facility.

Medical Device Establishment Registration

Required for Indian manufacturers and exporters of medical devices, diagnostic equipment, surgical instruments, and related products. Medical device establishments must register and list their devices annually. Products must also comply with FDA Quality System Regulation (QSR) and, in many cases, require 510(k) clearance or PMA approval before being marketed in the US.

Cosmetics Voluntary Registration

While cosmetics registration with the FDA is currently voluntary for most products, it is strongly recommended for Indian cosmetic exporters targeting the US market. A registered cosmetic business signals compliance awareness to US buyers, retailers, and distributors – and is increasingly expected by major retail chains as part of their vendor qualification process.

The US FDA Agent Requirement

Every non-US company that registers with the FDA is required to designate a US FDA Agent – a person or organisation based in the United States who acts as the official point of contact between your business and the FDA. The FDA uses the US Agent to communicate inspection notices, compliance requests, and other regulatory correspondence.

The US Agent must be physically located in the United States and available to the FDA at all times during US business hours. This can be a law firm, a regulatory consultant, an importer, or any individual with a US address willing to take on this responsibility. Failure to designate or maintain a valid US Agent is itself a compliance violation and can lead to registration cancellation.

Prior Notice for Food Shipments

For Indian exporters of food products, Prior Notice (PN) is a separate and critical compliance step that operates alongside Food Facility Registration. Before any food shipment is loaded onto a vessel or aircraft bound for the United States, a Prior Notice must be submitted to the FDA through the FURLS portal.

• Prior Notice must be submitted at least 4 hours before arrival at a US port for vessel shipments

• For air shipments, Prior Notice must be submitted at least 4 hours before arrival

• The Prior Notice must include details of the food product, manufacturer, shipper, importer, and country of origin

• Failure to submit Prior Notice – or submitting incorrect information results in the shipment being refused entry at the US port, held, or returned at the exporter’s expense

Prior Notice is not optional.

A food shipment that arrives at a US port without a valid Prior Notice on file will be refused entry by US Customs and Border Protection regardless of the product’s quality or the exporter’s FDA registration status. This is one of the most common and costly compliance mistakes made by first-time food exporters to the United States.

Ongoing FDA Compliance for Indian Exporters

FDA registration is not a one-time filing that you complete and forget. It comes with ongoing compliance obligations that must be maintained continuously to keep your export operations running without interruption.

• Food Facility Registration must be renewed biennially every two years during the October to December renewal window

• Drug and Medical Device registrations must be renewed annually

• All facilities are subject to FDA inspections maintaining Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Points (HACCP) documentation is essential

• Any change in the facility ownership, address, products manufactured, or US Agent must be updated with the FDA within the prescribed timeline

• Products on the FDA Import Alert list face automatic detention at US ports avoiding this list requires consistent compliance with FDA standards

FDA Import Alert – a risk every Indian exporter must understand:

When the FDA finds repeated compliance violations from a specific exporter or facility, it places them on an Import Alert. Every subsequent shipment from that facility is automatically detained at the US port – regardless of the individual shipment’s quality. Getting off an Import Alert list is a lengthy and expensive process. Prevention through consistent compliance is the only reliable strategy.

DUNS Number Registration for Indian Exporters

A DUNS Number Data Universal Numbering System is a unique 9-digit identifier assigned by Dun and Bradstreet (D&B) to every business entity globally. It functions as a universal business identity credential that is recognised across international trade, banking, government procurement, and e-commerce supply chains.

For Indian exporters targeting the United States and other global markets, a DUNS Number has moved from being optional to being practically essential. It is now required for FDA Facility Registration, for applying to US government contracts and federal procurement programmes, and for registering as a seller on major US e-commerce and supply chain platforms.

Documents Required for US FDA and DUNS Registration

For both registrations, the documentation required from Indian exporters overlaps significantly. Having these documents ready before starting either application avoids delays:

• Business registration documents Certificate of Incorporation, Partnership Deed, or MSME/Udyam Certificate

• PAN Card of the business entity

• GST Registration Certificate

• IEC (Import Export Code) issued by DGFT, mandatory for food and pharma exporters

• FSSAI Licence required for food exporters registering for FDA Food Facility Registration

• Business address proof utility bill or rent agreement for the manufacturing or processing facility

• Details of the US FDA Agent name, US address, and contact information

• List of products to be exported with HSN codes and product descriptions

• Manufacturing facility details layout, GMP compliance status, HACCP documentation for food facilities

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