Keywords: FDA risk methodology, pharmaceutical manufacturing sites, CAPA, current good manufacturing practices, cGMP, warning letters, medical devices, FDA assessment, USA, United States, Food and Drug Administration, risk assessment, FDA performance
Assessing FDA's risk methodology at pharmaceutical manufacturing sites
This research analyses the US Food and Drug Administration's (FDA's) risk methodology used for inspecting pharmaceutical manufacturing sites. It reviews the procedures, regulations, and violations specified in FDA warning letters (WLs). In particular it focuses on the time period between 2004-2009, as the FDA transitioned and formalised this new approach to site inspections. One of the principal outcomes of this study is to gauge the FDA's performance and assess its new methodology.