FDA overseas offices lag behind FSMA inspection mandate
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WASHINGTON, March 2 -- The Food and Drug Administration (FDA) is not keeping pace with a mandate that requires its overseas offices to inspect foreign food facilities, according to a Government Accountability Office (GAO) report.
In 2008, FDA established foreign offices to help prevent unsafe products from reaching U.S. borders. The Food Safety Modernization Act (FSMA), signed into law by President Barack Obama in January 2011, directed FDA to inspect at least 600 foreign food facilities in 2011 and double the number of inspections each year for the next five years.
Although FDA completed more than the requirement for 2011, with 1,002 inspections, it finished only 1,343 such inspections in 2012, a 34 percent increase from the previous year but not twice as many, as mandated. During 2013, FDA completed 1,403 such inspections, a 4 percent increase from the previous year but also less than twice the previous year's number. According to information available so far, GAO said the agency completed 1,323 inspections in 2014.
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The GAO said FDA needs to conduct an analysis to determine the number of inspections needed to ensure that imported food is safe.
“Without such an analysis, FDA is not in a position to know what is a sufficient number of foreign inspections and, if appropriate, request a change in the mandate,” according to the report.
GAO said if the inspection numbers from this evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and suggest lawmakers make legislative changes.
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