Regulatory & Safety

US FDA looks to increase domestic, foreign drug manufacturer inspections

17-Mar-2014
Last updated on 17-Mar-2014 at 15:44 GMT2014-03-17T15:44:42Z - By Zachary Brennan
US FDA looks to increase domestic, foreign inspections
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The number of foreign inspections by the US FDA is expected to grow at a faster rate in FY 2015 than the increase in domestic inspections.

The inspection numbers were detailed in the HHS budget request for 2015, which notes that overseas inspections are expected to rise from 827 inspections to 999, while domestic facility inspections is only going to rise from 1,851 to 1,856.

The FDA inventory of high-risk establishments “is dynamic and subject to change,” HHS said. 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,” the agency said.

FDA has made inspecting high-risk domestic and foreign firms a priority, though high-risk establishment inspection frequencies currently “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.”

In 2013, the agency set a target of inspecting 750 high-risk facilities and in reality inspected 808. Field investigators inspected 443 domestic high-risk drug establishments and 365 high-risk foreign drug establishments. As a result of these foreign inspections, 43 Good Manufacturing Practices (GMP) based warning letters were issued.

The FDA also recently teamed with the EMA on generic site inspections, while back in October industry sought more clarity on how to delay or deny inspections.

The agency said it “will continue conducting for-cause inspections in response to adverse event reports, product quality complaints, and state requests.”

The FY 2015 Budget request also seeks additional resources to conduct additional proactive inspections of high-risk human drug compounding pharmacies, as well as follow-up inspections of pharmacies identified as needing to take corrective actions during previous inspections.

Related topics: Regulatory & Safety, QA/QC, APIs (active pharmaceutical ingredients), Regulations