Facilities, whether they are domestic or foreign, must be registered with the FDA. The activities that qualify for registration include manufacturing, testing, packaging and propagation of finished bulk drugs.
Drug Establishment site renewals must occur every year between October 1 to December 31. If the site is not renewed in that time period the establishment will be removed from FDA’s establishment registration database.
Foreign sites require a US agent. This agent acts as a point of contact for the FDA.