Title: Assessing FDA's risk methodology at pharmaceutical manufacturing sites

Authors: Warren Adis

Addresses: Hagan School of Business, Iona College, New Rochelle, NY, USA

Abstract: 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.

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.

DOI: 10.1504/IJBCRM.2010.035689

International Journal of Business Continuity and Risk Management, 2010 Vol.1 No.3, pp.259 - 270

Published online: 02 Oct 2010 *

Full-text access for editors Full-text access for subscribers Purchase this article Comment on this article