Among our services, we act as the U.S. agent for Spanish companies with the Food and Drug Administration (FDA). Serving as your U.S. FDA Agent, we manage the mandatory registration and furnish companies with vital import requirement details.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act/BTA) requires all domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.
This requirement also applies to companies that export medical devices, cosmetics and pharmaceutical drugs to the United States. For purposes of the registration, a foreign facility must designate a U.S. agent with a permanent physical presence in the United States.
The Spain-U.S. Chamber of Commerce acts as a communication bridge between the FDA and foreign facilities, handling both emergency and routine communications. The FDA contacts the designated U.S. agent in case of an emergency, unless another emergency contact is specified in the registration.
