Although your U.S. company does not need a U.S. Agent, your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment, is required to appoint one as part of the registration process.
What a U.S. Agent is not?
Commercial Agent
Customs Broker
Initial Importer
Importer of Record
FSVP Importer
https://www.fda.itbhdg.com/u-s-agent/

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