Typical Course of an FDA Inspection

An archive is established and meets all the criteria of protection against fire, flood, and other catastrophic data loss. 

Once the inspectors have entered the audit room, they are greeted by the representative of the management. Then, the exchange of business cards and personal presentation follow. The other participants introduce themselves as well as the management representative and hand over their business cards. This usually happens before the inspectors have taken a seat. After the inspection, the business cards are a valuable source of information on names and functions of the contact persons who participated in the inspection. It is common that the inspectors identify themselves to members of management with their identity card credentials and thus begin the official part of the inspection. 

Participants of the opening meeting are compiled from the persons in the audit room, back office, and other interested or maybe involved persons from the departments. The FDA inspectors are quite used to a larger number of participants in opening meetings. If the number of seats is limited, at least the persons directly involved in the audit room and the back office should take part in the opening 

The company presentation for the opening meeting should be created and presented in English, and the inspectors should be provided with a printout so that they can take notes for future reference. Later, it facilitates writing of the report for the inspectors. 

Overview of the company s name, affiliated group, headquarter, location(s) Overview of the economic indicators, number of employees, and so on Overview of the main products and markets, related to the US market Overview of the product focused by the current inspection, with information on history, processes, techniques, locations, subprocesses, key suppliers, or subcontractors, for example, sterilization process 

---