Here's a nice analysis of FDA inspections of foreign manufacturing sites provided by in-Pharma Technologist.com. The analysis breaks down inspections by country, pre-approval vs GMP, and indicates number and percentage of sites that have never been inspected.
As posted a couple of days ago here, the GAO was critical of the FDA's implementation of its foreign site inspection plan. While admittng that the FDA had improved, the GAO still criticized it as being too slow, and noted that a very large percentage of sites were still going completely uninspected. The GAO also criticized the FDA prioritization system which was biased toward pre-approval inspections instead of focusing on "problem sites" with higher potential impact on public safety. The FDA indicated that it needed more fundng to improve number of inspections abroad.
Posted by Bruce Lehr November 3rd 2010.
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