Inspection responsibilities depend on a manufacturing site's location, activities, target markets and applicable regulatory procedures — not simply on the name of a medicines agency. Understanding these factors helps manufacturers identify which authorities may inspect their facilities and how existing inspection results may be used by other regulators. Consider a manufacturing site producing an active pharmaceutical ingredient (API) for customers in Europe, China and India, while finished products made from that API are also registered in the Eurasian Economic Union (EAEU). For this site, "who will inspect us?" is not...