An FDA inspection involves more than the investigators who visit a manufacturing site. The reason for the inspection, the field team's findings and the agency's final classification are separate elements of a regulatory process. Understanding how these responsibilities are divided is essential for pharmaceutical manufacturers preparing for US market access or maintaining compliance. Article 1 in the “Mapping Inspection Systems” series. Following an overview of who may inspect a pharmaceutical manufacturing site, this article examines the US Food and Drug Administration's (FDA) inspection system in detail. The question “Will the...