§ 251.11. Official contact and U.S. agent for Foreign Sellers.
187 words·~1 min read·
/us/cfr/t21/s§ 251.11·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.