From DCAT Value Chain Insights (VCI)
In the US Department of Health and Human Services Fiscal Year (FY) 2015 budget request, released earlier this month, FDA outlined its progress in inspecting high-risk domestic and foreign facilities and its targets for FY 2015. FDA conducts inspections of both domestic and foreign high-risk drug establishments on a periodic basis for surveillance purposes. FDA has made inspecting high-risk domestic and foreign firms a priority and has set multiple performance goals for these high-risk facilities. In FY 2013, field investigators inspected a total of 808 high-risk drug establishments (443 domestic high-risk drug establishments and 365 high-risk foreign drug establishments), exceeding a target of inspecting. 750 establishments. As a result of these foreign inspections, 43 GMP-based Warning Letters were issued. For FY 2014 and FY 2015, FDA expects to maintain its target level of 750 high-risk inspections.
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