21 CFR § 207.69 - What are the requirements for an official contact and a United States agent?

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§ 207.69 What are the requirements for an official contact and a United States agent?

(a) Official contact. Registrants subject to the registration requirements of this part must designate an official contact for each establishment. The official contact is responsible for:

(1) Ensuring the accuracy of registration and listing information; and

(2) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications.

(b) United States agent. Registrants of foreign establishments subject to this part must designate a single United States agent. The United States 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 United States agent is not physically present. The United States agent is responsible for:

(1) Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;

(2) Responding to questions concerning those drugs that are imported or offered for import to the United States;

(3) Assisting FDA in scheduling inspections; and

(4) If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.

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