The presentation deals with investigative inspections as they are typically conducted by the FDA or other international regulatory authorities. It addresses typical mistakes that are often made in inspections, as well as misunderstandings that may even stem from a company's own lack of knowledge about the products that are registered on the US market. The presentation is based on a large number of supervised inspections on both sides, that of the manufacturer and that of the consultant preparing a company. The speaker will report on his experiences from the inspections themselves, which were supported as a qualified translator.