GAO-10-961 Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed
Last week the US Government Accountability Office (GAO) published a report assessing progress the US Food and Drug Administration (FDA) has made on overseas inspections.
In the report the GAO presented data showing: the top 10 most inspected overseas countries in 2007, 2008 and 2009; a breakdown of the type of inspection; and the percentage of sites that may never have been inspected. Data extracted by in-PharmaTechnologist is available here.
The number of sites that may never have been inspected “includes registered establishments whose drugs are being imported into the US, as well as establishments that may not actually be subject to inspection”, according to the GAO report.