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 FDA’s Center for Devices & Radiological Health sent 121 warning letters last year, the same number as in 2014, and issued 924 Form 483 notices containing 3,525 quality system observations, down -6%.
“Production and Process Controls and Corrective & Preventive Actions continue to be the most frequently cited QS subsystems,” the FDA said.
Most of the inspections conducted last year (45%) delivered “no action indicated” decisions, with “voluntary action indicated” found in 43% of cases and 11% ending with “official action indicated” judgments. Nearly half of U.S. inspections (49%) resulted in NAI decisions; 41% resulted in VAI decisions and 10% led to OAI calls.
Overseas, 39% of inspections led to NAI rulings, with 46% delivering VAI and 15% ending in OAIs, the FDA said. The most-inspected country was China, at 126, followed by Germany (90) and Japan (44), the agency said.
