All Facilities Must Appoint An U.S. Agent

 

As part of a Food or Device facility registration, each company outside the USA must appoint and notify FDA of their United States agent. The role of the U.S. agent is to act as a communications link between the facility and FDA, FDA will communicate with the U.S. agent in both routine and emergency situations. This means that we, as your U.S. agent, are accessible to FDA 24 hours a day, 7 days a week.

 

U.S. Agent An U.S. agent means a person residing or maintaining a place of business in the U.S. whom a foreign facility designates as its U.S. agent for purposes of the registration regulation. The U.S. agent acts as a communications link between FDA and the foreign facility. FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent equivalent to providing the information or documents to the foreign facility. Having a single U.S. agent for the purposes of registration does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes. A firm's commercial business in the U.S. need not be conducted through the U.S. agent designated for registration purposes. For independence reasons, we advise you to have a separate U.S. Agent from your importer, agent or customs broker in the USA.

 

Appoint Now We are here to assist and act as your U.S. Agent for the FDA.
   

Any payment option is accepted.
We accept credit card payments as well as bank transfers. All credit card payments are processed through our partner PayPal. If you prefer to pay by bank, we will send you an invoice first.

Solution Graphics
 


1. Select the service you want to purchase.
Below, you will find the option that allows you to assign us to act as your U.S. Agent.

2. Fill out the form.
Provide us with the information we need for the service. This form will take you less then 5 minutes to fill out.

3. Pay for the service.
You can pay online with your credit card, or you can request an invoice and pay by bank transfer. See our pricing.

 

 

 

 

 
  All inclusive price for one year:
 

U.S. Agent Appointment

 

We act as your U.S. Agent for all FDA food or device facility matters. Please follow the link to fill out our form.

 

 

295 USD

 

Including:

U.S. Agent

for

Food & Device

Facilities

 

 


Complete Solutions.
Our account with the FDA allows us to make submissions to FDA electronically via the Internet. FDA strongly encourages electronic submissions, which will be quicker and more convenient for both facilities and FDA.
Security is our Top Priority.
While using FDA Industry Systems (FIS), we comply with FDA standards on having current anti virus and antispyware software installed on our systems to help ensure the privacy of the information being entered.
Our Global Support.
We are specialized in supporting non-US based food facilities. Our processes are designed to process all registrations from companies located outside the USA.
Documentation.
You will receive a certificate of registration at the completion of the registration process with the FDA. This certificate can be used to notify all your trading partners. See a sample here.