§ 251.11 Official contact and U.S. agent for Foreign Sellers.

(a) Official contact. A Foreign Seller subject to the registration requirements of this part must designate an official contact. The official contact is responsible for: (1) Ensuring the accuracy of registration information as required by § 251.9; and (2) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications. (b) U.S. agent. (1) A Foreign Seller must designate a single U.S. agent. The U.S. agent must reside or maintain a place of business in the United States and may not be a mailbox, answering machine or service, or other place where a person acting as the U.S. agent is not physically present. The U.S. agent is responsible for: (i) Reviewing, disseminating, routing, and responding to all communications from FDA, including emergency communications; (ii) Responding to questions concerning those drugs that are imported or offered for import to the United States; and (iii) Assisting FDA in scheduling inspections. (2) FDA may provide certain information and/or documents to the U.S. agent. The provision of information and/or documents by FDA to the U.S. agent is equivalent to providing the same information and/or documents to the Foreign Seller.