Fee: $449 USD / Per Year
U.S. FDA Agent Services for Drug Establishments & Labelers
A U.S. FDA Agent is required for all foreign drug establishments and drug labelers that manufacture, pack, or label drug products and import those products into the United States.
As part of FDA Drug Establishment Registration and drug listing requirements, foreign facilities must designate a United States Agent (U.S. FDA Agent) to serve as the official liaison between the facility and the U.S. Food and Drug Administration (FDA).
Failure to appoint or maintain an active U.S. FDA Agent may result in:
Delays or rejection of FDA registration
Inability to import drug products into the U.S.
Increased regulatory risk during FDA inspections or inquiries
Responsibilities of a U.S. FDA Agent
The role of a U.S. FDA Agent is limited by FDA regulations and includes four primary responsibilities:
Assisting the FDA with communications involving the foreign drug establishment or labeler.
Responding to FDA questions or requests concerning the foreign establishment and its drug products.
Assisting the FDA in scheduling inspections of foreign drug establishments.
Receiving FDA information or documents on behalf of the foreign establishment if the FDA is unable to contact the facility directly or in a timely manner.
Any communication provided to the U.S. FDA Agent is considered legally equivalent to communication provided directly to the foreign establishment.
Why a Qualified U.S. FDA Agent Is Important
A reliable U.S. FDA Agent helps ensure:
Timely FDA communication
Accurate and prompt responses to FDA requests
Reduced risk of regulatory delays or enforcement action
Continuous compliance with FDA drug regulations
U.S. FDA Agent Services
FDA Registration Assistance is committed to providing dependable, professional U.S. FDA Agent services for foreign drug establishments and labelers.
Our services include:
Acting as your designated U.S. FDA Agent
Managing FDA communications on your behalf
Supporting FDA inspection coordination
Ongoing regulatory compliance support
To appoint FDA Registration Assistance as your United States Agent, please contact us today.
Frequently Asked Questions (FAQ)
What is a U.S. FDA Agent?
A U.S. FDA Agent is a U.S.-based representative designated by a foreign drug establishment or labeler to communicate with the FDA.
Who is required to have a U.S. FDA Agent?
All foreign drug manufacturers, repackers, and labelers importing drug products into the United States must appoint a U.S. FDA Agent.
Does the U.S. FDA Agent replace the importer or distributor?
No. The U.S. FDA Agent is not the importer of record and does not replace customs brokers, importers, or distributors.
Can the FDA contact my U.S. FDA Agent instead of my facility?
Yes. If the FDA cannot reach the foreign facility promptly, communication through the U.S. FDA Agent is considered legally equivalent.
Can I change my U.S. FDA Agent?
Yes. You may change your U.S. FDA Agent at any time by updating your FDA Drug Establishment Registration.
Can FDA Registration Assistance act as my U.S. FDA Agent?
Yes. FDA Registration Assistance provides professional U.S. FDA Agent services and ongoing regulatory support.
Contact FDA Registration Assistance
Appoint a trusted U.S. FDA Agent and ensure uninterrupted FDA compliance.
