US Agent Services
The 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. The U.S. 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 U.S. Agent are limited and include:
- Assisting FDA in communications with the foreign establishment
- Responding to questions concerning the foreign establishment’s drug or device products 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 U.S. Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.