FDA U.S. Agent UEI Number Guide for Drug Establishments

Introduction

For pharmaceutical companies planning to enter the United States market, compliance with the Food and Drug Administration is a legal requirement. One of the most critical compliance elements for foreign drug manufacturers is the appointment of an FDA U.S. Agent along with proper identification through the UEI number. Understanding how the FDA U.S. Agent system works, how the UEI number fits into registration, and how foreign companies can stay compliant is essential for smooth regulatory approval and uninterrupted business operations.

This article explains the role of an FDA U.S. Agent, the importance of the UEI number, registration steps, responsibilities, verification methods, and answers to common questions related to FDA numbers and product codes.

What Is an FDA U.S. Agent

An FDA U.S. Agent is a mandatory representative for all non United States drug establishments that register with the FDA. The agent acts as the primary communication link between the FDA and the foreign company. Without a designated U.S. Agent, a foreign drug establishment cannot complete FDA registration or legally market its products in the United States.

The FDA communicates regulatory notices, inspection information, and emergency alerts only through the appointed U.S. Agent.

Understanding the UEI Number in FDA Registration

The Unique Entity Identifier or UEI number is a government issued identifier used to uniquely recognize registered entities. The FDA now requires a UEI number instead of the older DUNS number for establishment registration and listing.

For drug manufacturers, the UEI number connects the establishment details, FDA registration records, and compliance history in a centralized system. Without a valid UEI number, FDA registration cannot be submitted or renewed.

Why the FDA U.S. Agent UEI Number Is Important

The FDA U.S. Agent UEI number ensures

Accurate identification of foreign establishments
Secure communication between FDA and manufacturers
Faster processing of registration and renewals
Reduced risk of regulatory delays
Traceability during inspections and audits

Any mismatch in UEI data can lead to registration rejection or compliance issues.

FDA U.S. Agent Responsibilities

The FDA U.S. Agent has legally defined responsibilities that include

Acting as the official contact point for FDA communication
Receiving inspection notifications and compliance letters
Responding to FDA queries on behalf of the foreign company
Assisting during emergency situations or recalls
Supporting annual registration renewals and updates

The U.S. Agent must be available during United States business hours and maintain accurate records.

How to Become a U.S. FDA Agent

To become a U.S. FDA Agent, an individual or organization must

Be physically located in the United States
Understand FDA regulatory requirements
Be authorized in writing by the foreign establishment
Maintain confidentiality and compliance standards
Possess the capability to respond promptly to FDA communications

Many companies prefer professional FDA consultancies to act as their U.S. Agent due to regulatory complexity and risk exposure.

FDA U.S. Agent Registration Process

The registration process includes

Obtaining a valid UEI number
Creating an FDA account
Registering the drug establishment annually
Appointing a U.S. Agent during registration
Submitting drug listing information

Errors in any step can delay approval or cause compliance violations.

Choosing a Reliable FDA U.S. Agent Service Provider

Selecting the right U.S. Agent is critical for long term compliance. A professional agent understands FDA expectations, communication protocols, and regulatory timelines.

FDA U.S. Agent services for drug establishments should include end to end support, compliance monitoring, and timely response to FDA notifications.

XPRO America is a trusted US FDA Consultancy that provides professional FDA U.S. Agent services along with drug establishment registration, UEI assistance, and ongoing compliance support. For companies seeking dependable regulatory representation, working with an experienced consultancy significantly reduces compliance risk.

How to Check U.S. FDA Registration Number

You can verify FDA registration by

Accessing the FDA registration and listing database
Searching using establishment name or registration number
Confirming listing status and expiration dates

Verification ensures that the registration is active and compliant.

What Is the Eleven Digit FDA Number

The eleven digit FDA number typically refers to the FDA establishment registration number assigned to registered facilities. This number identifies the manufacturing location within FDA systems and is used during inspections and audits.

What Is the FDA Establishment Registration Number

The FDA establishment registration number is a unique identifier assigned after successful registration. It confirms that the facility is legally registered with the FDA and permitted to manufacture or distribute regulated products.

Understanding the Seven Digit FDA Product Code

The seven digit FDA product code classifies regulated products based on industry, class, and specific product type. It helps FDA track product categories and apply appropriate regulatory controls.

How to Find an FDA Product Code

To find a product code

Use the FDA product classification database
Search by product type or intended use
Match regulatory category and product class

Correct product codes are essential for accurate listing and compliance.

What Is FDA Called in India

In India, FDA is commonly referred to as CDSCO which stands for Central Drugs Standard Control Organization. While CDSCO regulates India, FDA governs products entering the United States market.

How to Obtain an FDA Number

To obtain an FDA number

Appoint a U.S. Agent
Obtain a UEI number
Complete FDA establishment registration
Submit accurate facility and product details

Once approved, the FDA assigns the establishment registration number.

How to Check If the FDA Verified a Product

Product verification involves

Confirming product listing in FDA database
Reviewing regulatory status
Ensuring proper classification and compliance

FDA verification does not mean product approval but confirms registration and listing compliance.

How Do I Find a Product Code

Product codes can be found using FDA classification tools or with professional regulatory assistance. Accurate codes ensure proper listing and avoid regulatory errors.

FDA U.S. Agent in India

FDA U.S. Agent in India services are typically provided through authorized United States based representatives working with Indian manufacturers to ensure compliance with FDA requirements.

Final Perspective

An FDA U.S. Agent and a valid UEI number form the foundation of FDA compliance for foreign drug establishments. From registration to inspections, these elements ensure smooth communication and regulatory continuity. Partnering with an experienced U.S. Agent and consultancy like XPRO America, a dedicated US FDA Consultancy, helps businesses avoid costly mistakes and maintain uninterrupted access to the United States pharmaceutical market.

For professional assistance related to FDA U.S. Agent services, UEI number support, and drug establishment registration, you can reach the regulatory team at support@xproamerica.com for personalized guidance.