Roles &
Responsibilities of US Agent
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When registering with USFDA for importing food, medical device
and drugs, the agency legally insists manufacturing companies located outside
of the United States to designate a U.S. Agent for that establishment.
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Unlike QP in the EU market (QP involved in most aspects of the
drug product supply chain, with patient safety and product quality being
their personal responsibility),US agent does not have such bigger roles and
responsibilities.
US agent is only 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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