The lecture deals with the escalation of an FDA inspection in the form of a Warning Letter. It addresses common mistakes that are often made. In addition, misunderstandings often arise from a lack of proficiency regarding the products sold on the American market. The lecture is based on a large number of inspections that have been supervised in various roles. These include the role of the manufacturer and that of the consultant and coach who prepares a company. The lecturer reports on experiences, analyzes and consultancy assignments.