Introduction
Entering the United States pharmaceutical market requires more than product quality and manufacturing capability. Regulatory compliance with the Food and Drug Administration is mandatory for every foreign drug establishment. One of the most important compliance requirements is appointing an FDA U.S. Agent and completing registration using a valid UEI number.
Many companies struggle to understand how the U.S. Agent role works, what the UEI number represents, and how these elements connect to FDA registration and product listing. This article provides a complete explanation in simple terms so foreign manufacturers can confidently meet FDA expectations.
What Is an FDA U.S. Agent
An FDA U.S. Agent is an individual or organization located in the United States that represents a foreign drug establishment. The FDA requires this appointment so it has a reliable contact within the United States for communication related to inspections, compliance, and emergencies.
Without an appointed U.S. Agent, a foreign company cannot complete FDA drug establishment registration. The U.S. Agent does not own the products but serves as the official bridge between the FDA and the overseas manufacturer.
Role of the UEI Number in FDA Compliance
The Unique Entity Identifier or UEI number is now a core requirement for FDA establishment registration. It is a government issued identification number used to uniquely identify registered entities across federal systems.
For FDA purposes, the UEI number links the establishment identity, ownership details, and compliance records. The FDA no longer accepts DUNS numbers, making the UEI mandatory for all new registrations and renewals.
Why FDA U.S. Agent UEI Number Matters
The combination of a U.S. Agent and UEI number ensures transparency and traceability. The FDA relies on this information to confirm the legitimacy of foreign establishments.
Key benefits include
Accurate establishment identification
Faster FDA communication
Reduced registration delays
Clear inspection coordination
Improved compliance tracking
Any incorrect UEI data or unresponsive U.S. Agent can result in registration rejection or regulatory action.
FDA U.S. Agent Responsibilities in Detail
The FDA U.S. Agent carries several responsibilities that directly affect compliance status
Receiving official FDA communications
Responding to inspection notices
Supporting emergency and recall situations
Facilitating regulatory correspondence
Assisting with registration renewals
The agent must always be reachable during United States business hours and maintain updated authorization from the foreign company.
How to Become a U.S. FDA Agent
To act as a U.S. FDA Agent, the following conditions must be met
Physical presence in the United States
Written authorization from the foreign establishment
Knowledge of FDA regulations
Ability to respond promptly to FDA inquiries
Commitment to confidentiality and compliance
Because of the legal responsibility involved, many companies choose professional regulatory consultancies rather than individuals.
FDA Drug Establishment Registration Overview
Drug establishment registration is an annual requirement. The process includes
Obtaining a UEI number
Creating an FDA submission account
Entering establishment information
Appointing a U.S. Agent
Submitting drug listing data
Failure to renew registration on time may lead to product refusal at United States ports.
Selecting Professional FDA U.S. Agent Services
Choosing the right U.S. Agent is a strategic decision. Experience, responsiveness, and regulatory knowledge matter more than cost alone.
US FDA Agent services for foreign drug manufacturers should include regulatory communication management, UEI guidance, inspection readiness support, and renewal reminders.
XPRO America operates as a specialized US FDA Consultancy offering FDA U.S. Agent representation, drug establishment registration, UEI support, and ongoing compliance assistance. Working with a professional consultancy reduces regulatory risk and ensures consistent FDA communication.
How to Check US FDA Registration Number
FDA registration status can be verified through the official FDA registration and listing system. Users can search using
Establishment name
Registration number
Owner or operator details
This verification helps confirm whether a facility is actively registered and compliant.
What Is the Eleven Digit FDA Number
The eleven digit FDA number refers to the establishment registration number assigned after successful registration. This number is used by the FDA to identify manufacturing sites during inspections and regulatory reviews.
FDA Establishment Registration Number Explained
The FDA establishment registration number confirms that the facility has met registration requirements. It does not mean product approval but indicates that the establishment is listed within FDA systems.
Understanding the Seven Digit FDA Product Code
The seven digit FDA product code categorizes regulated products. It reflects industry type, product class, and specific characteristics. Correct product codes are essential for accurate drug listing.
How to Find FDA Product Codes
Product codes can be located by
Using FDA product classification tools
Reviewing similar approved listings
Consulting regulatory experts
Incorrect product codes may cause listing errors or compliance delays.
FDA and India Regulatory Comparison
In India, drug regulation is handled by CDSCO which stands for Central Drugs Standard Control Organization. While CDSCO regulates domestic products, FDA requirements apply to products entering the United States market.
How to Obtain an FDA Number
To obtain an FDA number, a company must
Complete establishment registration
Appoint a U.S. Agent
Provide a valid UEI number
Submit accurate facility information
After submission, the FDA assigns the establishment registration number.
How to Check If FDA Verified a Product
FDA verification focuses on registration and listing. Companies can check if a product is listed by reviewing FDA databases. Listing confirms compliance but does not imply FDA approval.
How to Find a Product Code Correctly
Finding the correct product code requires understanding product composition and intended use. Regulatory guidance or professional assistance ensures accuracy and avoids compliance risks.
FDA U.S. Agent in India Support
Many Indian pharmaceutical companies use FDA U.S. Agent in India services through United States based representatives. These services help Indian manufacturers comply with FDA regulations efficiently.
Closing Insight
An FDA U.S. Agent and a valid UEI number are not optional for foreign drug establishments. They are fundamental compliance requirements that support communication, traceability, and regulatory control. Companies that invest in professional FDA representation benefit from smoother registrations and reduced regulatory risk.
For reliable FDA U.S. Agent services, UEI number assistance, and drug establishment registration support, foreign manufacturers may consult the regulatory specialists at XPRO America. For tailored compliance guidance, inquiries can be directed to the team via support@xproamerica.com.
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