Newly released government data shows the FDA has been conducting more quality systems inspections at foreign devicemakers to keep up with rapidly growing inventory at those manufacturers.
From 2014 to 2015, foreign inspections climbed more than 4 percent to 620, while domestic inspections fell more than 8 percent to 1,484, the data show.
In time, the goal is to achieve parity in the number of foreign and domestic inspections that are performed by FDA investigators in any given year, said Sean Boyd, acting director of CDRH’s Office of Compliance.
Meanwhile, overall inspections decreased nearly 5 percent to 2,104 from 2014 to 2015, according to the data.
The decrease in the number of surveillance inspections is the result of shifting resources from foreign to domestic inspections, Boyd said.
“There is more time required to plan and conduct foreign inspections compared to domestic, as well as shifting resources towards risk-based approaches and site selection of firms that we believe need more interaction with the FDA to resolve issues,” he said.
CDRH sent 121 warning letters in 2015, the same amount as the year before. CRDH also issued 924 Form 483s, a decrease of more than 16 percent from the previous year. Those 483s contained 3,525 observations, a decrease of nearly 6 percent versus 2014.
Production and process controls and corrective and preventive actions continue to be the most frequently cited QS subsystems, the FDA says.
China led the way among the top five locations last year with 126 inspections, followed by 90 in Germany, 44 in Japan, 42 in Canada and 35 in United Kingdom, according to the data. The top three countries for 2015 remained the same as in 2014.
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