Complete US FDA Facility Registration, Product Listing & Mandatory US Agent Representation
Entering the US market requires strict compliance with US FDA (Food and Drug Administration) safety and traceability standards. Under the Food Safety Modernization Act (FSMA) and MoCRA, any business manufacturing, processing, packing, or holding food, beverages, dietary supplements, cosmetics, pharmaceuticals, or medical devices for US export must register its facility and maintain an authorized US Agent. Failure to register results in immediate shipment detentions at US ports of entry by US Customs (CBP). SetCorpTax manages your complete US FDA lifecycle—from DUNS number validation and FURLS facility registration to product listings and US Agent representation.
Why Official US FDA Registration is Mandatory for Exporters
Obtaining your US FDA registration is a mandatory prerequisite before shipping commercial goods to the United States. The FDA inspects shipments at entry ports, cross-verifying Prior Notice filings against active Facility Establishment Identifiers (FEI) and Food Facility Registrations (FFR).
Non-compliance or invalid US Agent credentials lead to immediate import refusals, commercial blacklisting, and severe financial penalties. Furthermore, biennial renewal requirements (October–December of even-numbered years for food facilities) mean your registration must be actively monitored. SetCorpTax provides an all-in-one compliance bridge, handling technical portal submissions, product classification, ingredient labeling checks, and seamless US Agent coordination to ensure customs clearance without port holds.
How Your US FDA Registration is Processed
Document & DUNS Verification
Upload your business registration, factory address proof, product category list, and DUNS number to your SetCorpTax compliance workspace.
Official Portal Submission
Our regulatory consultants draft your application on the official FDA FURLS system, assign the authorized US Agent, and complete mandatory product/facility category declarations.
FDA Registration Issuance
Receive your official FDA Registration Number, PIN, and Certificate of Registration for immediate use on shipping documents, commercial invoices, and Prior Notice declarations.
FDA Regulated Product Categories Handled
Food, Beverages & Dietary Supplements
Cosmetics & Personal Care (MoCRA)
Medical Devices (Class I, II & III)
Pharmaceuticals & OTC Drugs
FDA Labeling & Ingredient Review
Biennial Renewal & Profile Sync
Empowering Partners Through Transparent Pricing
Food Facility Registration
₹7,999* (Facilitation Fee)
Ideal for Indian food, agro, spice, and supplement exporters shipping to the USA.
Complete FURLS Food Facility Registration (FFR)
DUNS Number Alignment & Verification Check
INITIATE FOOD REGISTRATION
MoCRA Cosmetic Suite
₹11,999* (Professional Pack)
Comprehensive compliance package for skincare, haircare, and cosmetic brand exporters.
MoCRA Cosmetic Facility Registration (FEI Allocation)
Product Ingredient & Formulation Listing (up to 5 products)
US Agent Representation & Packaging Review
Medical Devices / OTC Suite
₹24,999* (Enterprise Package)
End-to-end regulatory support for medical device establishments and OTC drug manufacturers.
FDA Establishment Registration & Device/Drug Listing
510(k) Pre-Screening & Classification Support
Dedicated Regulatory Consultant & Annual US Agent Service
10K+
Startups Registered
Successfully incorporating and scaling ambitious businesses across all states in India.
15 Days
Average Timeline
Rapid digital processing that bypasses legacy red tape to deliver quick certifications.
99.6%
Name Approval Rate
Driven by thorough pre-checks against Ministry of Corporate Affairs and Trademark databases.
F.A.Q.
Frequently Asked Questions Regarding US FDA Registration
No. The US FDA does not issue approval certificates for individual food, cosmetic, or standard dietary supplement products. Instead, it requires Facility Registration to ensure traceability. Only specific high-risk drugs, biologics, and Class III medical devices receive formal pre-market “Approval”.
The US FDA strictly mandates that foreign facilities appoint a domestic US Agent who resides or maintains a physical place of business in the United States. The US Agent acts as the operational communication link between the FDA and your foreign manufacturing facility for scheduling audits, emergencies, and shipment inquiries.
An FEI (Facility Establishment Identifier) is a unique 10-digit identification number assigned by the FDA to track inspections, registrations, and facility history. It is automatically assigned after successful FURLS registration.
Yes. The FDA requires all registering facilities to provide a valid Data Universal Numbering System (DUNS) number. The facility name and physical address on your FDA registration must match your DUNS record to prevent auto-rejection.
All food facilities registered with the FDA must renew their registration every two years during the window between October 1 and December 31 of every even-numbered year (e.g., 2026, 2028).