This research describes how the FDA has incorporated risk analysis methodology into its inspection of pharmaceutical manufacturers in the time period between 2004-2008. It analyzes the violations specified in FDA warning letters that are issued after site inspections of pharmaceutical facilities. The outcome of this analysis is to evaluate the FDA’s performance to determine whether it has improved the overall inspection process and increased its quality assurance
"Analysis of FDS’s Risk Assessment Methodology at Pharmaceutical Manufacturing Site,"
Communications of the IIMA: Vol. 9
, Article 1.
Available at: http://scholarworks.lib.csusb.edu/ciima/vol9/iss1/1