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Representing Foreign Manufacturers from Registration to Distribution

US Agent and FDA Official Correspondent

QA/RA Consulting Group, Inc. provides US Agent and Official Correspondent services to international clients. With years of experience dealing directly with FDA, we can give you peace of mind as the initial point of contact between your company and FDA. We will handle each issue with the care and sense of urgency it requires.

FDA US Agent

Foreign manufacturers are required to appoint a US Agent during Establishment Registration. This registration requirement applies to the following categories of foreign establishments:

Primary Manufacturers
Contract Manufacturers and Remanufacturers
Contract Sterilizers
Foreign Exporter of devices located in a foreign country
Specification Developers/Reprocessors of single use devices

A U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. Agent cannot use a post office box as an address or an answering service. The U.S. Agent must be available to answer the phone or have an employee available to answer the phone during normal business hours.

As your U.S. Agent, we will:

assist you with communications with the FDA;
respond to FDA questions concerning your devices that are imported or offered for import into the United States;
assist you in scheduling FDA inspections; and
if the FDA is unable to contact you directly or expeditiously, we will receive the information or documents on your behalf and forward them to you.

FDA Official Correspondent

An Official Correspondent simplifies communications and registrations with the FDA. As an FDA-registered entity, QA/RA Consulting Group will be responsible for your annual registration and the device listings and will handle most registration-related FDA responsibilities.

As your Official Correspondent, we will:

Handle annual registration and listing, including:
- Creating new registrations and listings;
- Canceling obsolete registrations and listings; and
- Changing/updating registration and listing information
Maintain and a current list of officers and directors and submit it to the FDA upon request; and
Receive pertinent correspondence from the FDA on your behalf.

US Agent Inquiry Form

US Agent Form

QA/RA strives to make compliance simple. Partner with a trusted FDA compliance expert to handle your FDA obligations. We also provide initial importer services, learn more here.