ABSTRACT
Chapter 9 focuses on the Food and Drug Administration (FDA) agency audits in regards to biologic, pharmaceutical, and medical device industries. The initial sections of this chapter focus on the traditional roles played by the CBER, CDER, and CDRH divisions within the FDA, and how the agency audits and the types of audits specifi c to each branch have been traditionally managed. This is followed by a section that focuses on inspections of manufacturers of combination products and some of the challenges these manufacturers face at present.
