U.S. Medical Device Inspections Down In 2015, FDA Reports
The FDA said this week that it inspected fewer U.S. medical device plants last year than in 2014, but sent inspectors to more overseas facilities.
The overall number of quality systems inspections fell -5% to 2,104 during calendar 2015, the federal safety watchdog said, but U.S. inspections were down -5% to 1,484 while foreign inspections rose 4% to 620, compared with 2014.
“The agency has been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly,” the FDA said.
The overall number of quality systems inspections fell -5% to 2,104 during calendar 2015, the federal safety watchdog said, but U.S. inspections were down -5% to 1,484 while foreign inspections rose 4% to 620, compared with 2014.
“The agency has been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly,” the FDA said.