observations on a 483. The authority to do so is granted by 21 CFR 1271 Subpart F.

The U.S. FDA has jurisdiction only within the United States. However, the supply chain for pharmaceuticals often extends far beyond the boundaries of the U.S., so the agency has an interest in assuring that foreign operations part of the U.S. supply chain are in an appropriate state of control, even though they have no legal authority to do so -- although they can restrict importation