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https://www.proregulations.com/u-s-fda-agent-for-foreign-companies.html

Science and Technology

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of devices, drugs, food, and cosmetics imported into the United States must identify a United States agent (U.S. agent) for that establishment. The U.S. agent acts to communicate between the FDA and foreign companies. For more information about the annual U.S. agent fee per year please contact us.