US FDA & DUNS Number Registration for Indian Exporters

US FDA & DUNS Number Registration for Indian Exporters!

1. US FDA Registration
What is US FDA Registration?
Indian exporters of food, pharmaceuticals, medical devices, cosmetics, and other FDA-regulated products must register with the US Food and Drug Administration (FDA). This ensures compliance with US safety and quality standards before exporting products to the USA.
________________________________________
Process to Obtain US FDA Registration

Step 1: Identify the Registration Type
Different product categories require different FDA registrations:
• Food Facility Registration (FFR) – For food manufacturers, processors, packers, and storage facilities.
• Drug Establishment Registration – For pharmaceutical companies exporting medicines.
• Medical Device Establishment Registration – For medical equipment exporters.
• Cosmetics Voluntary Registration – Not mandatory but recommended.

Step 2: Appoint a US FDA Agent
Non-US companies must designate a US FDA Agent who acts as the point of contact for all FDA-related communications. This agent can be a legal firm, consultant, or importer based in the USA.

Step 3: Submit the FDA Registration Application
• Complete the online FDA Registration Form via the FDA Unified Registration and Listing System (FURLS).
• Provide business details, product details, and facility information.
• For food exporters, submit the Food Facility Registration (FFR) Form under the Bioterrorism Act.

Step 4: Obtain FDA Registration Number
• Once registered, the FDA provides a Registration Number for the facility.

Step 5: Prior Notice for Food Shipments
• Before exporting food products, a Prior Notice (PN) must be submitted to the FDA at least 24 hours before shipment arrival in the USA.
• Failing to submit PN can lead to shipment rejection at US customs.

Step 6: Compliance with US FDA Regulations
• Ensure compliance with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) (for food), Drug Listing Requirements, and other applicable regulations.
• If required, undergo an FDA Inspection before approval.
________________________________________

2. DUNS Number Registration

What is a DUNS Number?
A D-U-N-S (Data Universal Numbering System) Number is a unique nine-digit identifier issued by Dun & Bradstreet (D&B). It is required for:
• US FDA Facility Registration (mandatory for pharma, medical, and food businesses).
• Business verification for US importers, banks, and government tenders.
• Exporters registering on US e-commerce and supply chain platforms (Amazon, Walmart, etc.).
________________________________________
Process to Obtain a DUNS Number
Step 1: Visit the D&B Website
• Go to the Dun & Bradstreet India website or the DUNS Request Portal.
• Choose the correct application type (business verification, government contracts, etc.).

Step 2: Submit Business Information
Provide the following details:
• Business name, address, and contact details.
• Ownership details (proprietorship, partnership, private limited, etc.).
• Business registration certificate, PAN, and GST details.
• Nature of business and industry classification.

Step 3: Verification by Dun & Bradstreet
• D&B will verify the business details through phone calls, email verification, and document validation.
• If additional details are required, D&B will request clarification.

Step 4: Receive the DUNS Number
• Upon approval, D&B assigns a unique 9-digit DUNS Number to your business.
• The DUNS Number is linked to your business profile and is required for global trade transactions.

Key Points for Indian Exporters
✔ US FDA Registration is mandatory for food, pharma, and medical exports to the USA.
✔ A US FDA Agent is required for non-US businesses.
✔ DUNS Number is essential for FDA registration, trade verification, and supply chain transactions.
✔ Both registrations are separate but interlinked, as the FDA now mandates a DUNS number for facility registrations.
________________________________________
Need Assistance?
xLegal provides end-to-end support for:
✅ US FDA Registration (Food, Pharma, Medical Devices, etc.)
✅ DUNS Number Registration for Indian Exporters
✅ Regulatory Compliance & Documentation for seamless exports

Contact us today at +91 9319661668,  for hassle-free registration and compliance!