FDA Seeks to Maintain Inspections of High-Risk Facilities in FY 2015

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-17-2014 18:06


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.  

Important features of the risk-based model are to reduce the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for risk; including both inherent risk (outbreaks, Class I recalls, adverse events) and compliance history. FDA continues to enhance its risk-based compliance and enforcement activities by increasing inspections of registered manufacturers, which are essential for meeting national public health objectives. These products involve complex manufacturing processes and are in limited supply in some cases. The FDA inventory of high-risk establishments is dynamic and subject to change. For example, firms go out of business, new high-risk firms enter the market, or the definition of high risk evolves based on new information on hazards. High-risk establishment inspection frequencies vary depending on the products produced and the nature of the establishment. Inspection priorities may be based on a firm’s compliance history or sample results.

Source: US Department of Health and Human Services

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