Importing into the United States and into its highly regulated markets can be confusing, complex, and costly -- particularly if you lack the information you need to comply with the myriad of federal & state regulatory requirements. Once you make that first attempt, you may find a US agency refuses to allow your product across the border, out of Customs custody, or into the U.S. market. This can be very costly to you and your importing clients.
As part of a Food, Drugs, Cosmetics or Device facility registration, each company outside the USA must appoint and notify FDA of their United States agent. The role of the U.S. agent is to act as a communications link between the facility and FDA, FDA will communicate with the U.S. agent in both routine and emergency situations. This means that we, as your U.S. agent, are accessible to FDA 24 hours a day, 7 days a week. U.S. Agent An U.S. agent means a person residing or maintaining a place of business in the U.S. whom a foreign facility designates as its U.S. agent for purposes of the registration regulation. The U.S. agent acts as a communications link between FDA and the foreign facility.
FDA will treat representations by the U.S. agent as those of the foreign facility, and will consider information or documents provided to the U.S. agent equivalent to providing the information or documents to the foreign facility. Having a single U.S. agent for the purposes of registration does not preclude facilities from having multiple agents (such as foreign suppliers) for other business purposes.