Foreign inspection worries keep FDA on GAO risk list
The GAO has again included the FDA in its high-risk series because of shortcomings in the oversight of overseas manufacturing facilities.
In the high-risk series, created in January 2009, the US Government Accountability Office (GAO) details public operations that are vulnerable or need to be overhauled. The US Food and Drug Administration (FDA) was the focus of one of 30 topics in the first list and remains in the series.
Changes called for by the GAO include: strengthening of resource management; creation of a workforce plan for overseas offices; and adoption of a more risk-based inspection policy.
“Part of meeting these challenges will require that the agency’s management foster a culture in which managers and staff identify, understand, value, and implement meaningful metrics”, says the GAO.
