Regulatory Focus™ > News Articles > US: IoM Report Calls FDA Inspections Impractical

US: IoM Report Calls FDA Inspections Impractical

Posted 05 April 2012 | By Ansis Helmanis

In its report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad, the Institute of Medicine (IOM) underscores that the US Food and Drug Administration's (FDA) traditional method of ensuring product safety-periodic inspections is impractical.

FDA currently inspects 20 million types of products manufactured at 300,000 factories in 150 different countries and imported through 300 ports of entry.

IOM's report states FDA "needs management systems that enable the agency to target resources to the greatest risks" and that "the FDA cannot continue to do its job well without substantive improvements in the capacity of counterpart agencies in emerging economies." 

Read more:

IOM: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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