Communications of the IIMA


This research details the FDA's quality systems methodology used in its inspection of biopharmaceutical manufacturers in the time period between 2003 and 2009. It analyzes the violations specified in FDA site inspection warning letters, reviewing their frequency and specificity. This analysis is an exploration into FDA activity in this sector, focusing particularly on finished pharmaceuticals, and serves as an initial evaluation of the FDA’s performance. In addition, the study pays particular attention to whether the FDA’s risk methodology has enhanced the overall inspection process and increased its quality assurance.