Willow Glen Proudly Offers:
$279 USD FDA Food Facility & Medical Facility Registration & FDA US Agent
FDA Certificate of Registration
Willow Glen FDA registration & certification!
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FDA US Agent (FDA Agent)
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (FDA US Agent or FDA Agent) for that establishment.
Information about a foreign establishment’s US FDA Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one US FDA Agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the US FDA Agent.
The US FDA Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the FDA US Agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the US FDA Agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new FDA US Agent to satisfy the regulatory obligation.
Responsibilities of a US FDA Agent
The US FDA Agent must either reside in the US or maintain a place of business in the US. The US FDA Agent cannot use a post office box as an address. The US FDA Agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.
The responsibilities of the US FDA Agent are limited and include:
Assisting FDA in communications with the foreign establishment.
Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment.
If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US FDA Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.