A roundup of the FDA’s Quality System program for 2015 shows 2,104 inspections, compared to 2,213 in 2014, a decrease the FDA calls “slight.” The Quality System program began in the mid-1990s and is designed to ensure ongoing safety and quality in the design, manufacturing, packaging, labeling, storing, and servicing of medical devices. The FDA can inspect facilities used by medical device manufacturers as well as issue warning letters to potentially non-compliant manufacturers under the regulation.
Despite the drop of around 5% in inspections overall, inspections of non-U.S. manufacturers rose from 594 in 2014 to 620 in 2015. China and Germany accounted for most of the foreign inspections, with 126 and 90 respectively. No other country had more than 50 inspections last year. The FDA noted that it has “been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly.”
The number of warning letters issued by the FDA under the Quality System program remained the same from 2014 to 2015, at 121 warning letters. The number of warning letters issued by the FDA had previously been decreasing by about 20 per year.
The FDA hopes that by releasing this data, industry can “improve device quality by sharing common observations from inspections” and avoid receiving warning letters.
The report was prepared by the FDA’s Center for Devices and Radiological Health, which promotes safety and innovation in the medical device field.