FDA US Agent for Foreign Facility Registration

We specialize in assisting foreign facilities in Medical Device Establishments and Drug facilities registered with FDA.

Our US Agent services can help you complete your facility registration, which is important for the sale of your products in the United States. We also provide a wide range of other services that make it easy to sell your products in the United States.

More Than Just a US Address: FDA US Agent

A US Agent is a person who has the authority to act on behalf of your company. A US Agent can help you get your food, drug, medical device, or dietary supplement foreign facility into compliance with FDA regulations and handle any aspects related to an FDA inspection.

The role of an FDA US Agent is often underutilized by companies looking to import foods, supplements, devices, or drugs from abroad, but it can be extremely helpful when dealing with the FDA. Below are some examples of why having this type of representation could be essential:

Handling warning letters from the FDA
Ensuring proper handling of recalls
Planning for reinspection requests

Our FDA US Agent Services

The United States Food and Drug Administration (FDA) has strict regulations when it comes to foods, medical devices, dietary supplements and drug products. If you are planning on selling your products in the US, you need to make sure they meet all of the requirements and guidelines set by the FDA, including requirements for your establishments.

The main role of a US agent is to help foreign companies comply with FDA regulations so that they can sell their products without any issues. They also act as a point of contact for the FDA to communicate with foreign companies. A good US agent will be able to guide you through the facility registration process smoothly so that you don’t have any trouble dealing with regulatory bodies such as the FDA later on down the road.

Why the FDA US Agent Service Is Required

Any foreign facility involved in manufacturing, preparing, propagating, compounding, or processing medicines, medical devices, or dietary supplement products imported into the US must appoint a US Agent as its official correspondent. Legally, the US Agent must have a residence in the US and be physically present. Responsibilities of the US Agent include:

Helping the FDA communicate with the foreign company
Being available in an emergency for the FDA
Serving on behalf of the foreign facility to interact with the FDA
Responding to questions concerning the foreign establishment’s drug, device or supplement products

In case of being unable to contact the foreign company expeditiously or directly, the FDA provides documents or information to the US Agent. Such action is considered equivalent to providing the same information or documents to a foreign establishment.

Our Responsibilities as the FDA US Agent

Over the years, we have successfully represented many foreign establishments as their US Agent Service provider. We specialize in assisting foreign Dietary Supplements Facilities, Food and Beverage Facilities, Medical Device Establishments, and Drug Establishments registered with FDA. Besides fulfilling all the responsibilities listed above, we also serve as a reliable liaison between clients and the FDA. We will help you:

Re-inspect your establishment
Handle your product detained at a US port
Ensure proper communications with the FDA
Schedule and negotiate FDA inspections
Address compliance questions that may come your way
Answer your questions fully and accurately
Help you understand the FDA’s requirements for foods, dietary supplements, drugs, and medical devices
Help you understand the FDA’s requirements for US Agents

A US Agent is an important part of the facility registration process

A US Agent is an important part of the facility registration process. Here are a few things you should know about them:

A US Agent is an individual or entity that has a written agreement with you (the “principal”) to act on your behalf in dealing with the US Food and Drug Administration (FDA).
A US Agent may be required if you are located outside of the United States and want to import your food, supplements, medical devices or drug products into the United States for sale.
All communication from the FDA – such as regulatory compliance issues, product-related problems, or inspection schedules – will come through the US Agent, so it’s important that the US Agent you choose has a clear understanding of all regulatory compliance matters.

Frequently Asked Questions

Why is a US Agent required for foreign facilities?

Any foreign facility involved in manufacturing, preparing, propagating, compounding, or processing medicines, medical devices, or food and beverage products imported into the US must appoint a US Agent as its official correspondent. The US agent is responsible for:

Helping FDA communicate with the foreign company
Being available in an emergency as the FDA contacts no other personnel
Serving on behalf of the foreign facility to interact with the FDA
Responding to questions concerning the foreign establishment’s products

Why should we choose Quality Smart Solutions for US Agent services?

Over the years, we have successfully represented many foreign establishments as their US Agent Service provider. We specialize in assisting foreign Dietary Supplements Facilit ies, Food, and Beverage Facilities, Medical Device facilities, and Cosmetic facilities registered with the FDA. Besides fulfilling all the responsibilities, we also serve as a reliable liaison between clients and the FDA. We will help you:

Re-inspect your establishment
Handle your product detained at a US port
Ensure proper communications with the FDA
Schedule and negotiate FDA inspections

Address compliance questions that may come your way

Does a US Agent have to physically reside in the U.S.A?

Yes, the US Agent must have a residence in the US and be physically present.