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Medical Devices / Inspections and Audits

FDA Boosts Foreign Device Inspections By 243 Percent

Dec. 5, 2018

The FDA has increased its foreign device inspections by 243 percent since 2007, according to a new quality and enforcement report.

Medical device manufacturing has become “an increasingly global enterprise,” with more than 21,000 registered manufacturers located in 106 countries, the agency said. It conducted 2,952 device inspections in 2017, representing a 46 percent increase since 2007.

In addition to FDA inspections, the agency received nearly 600 Medical Device Single Audit Program (MDSAP) reports from 2013 to 2017.

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