• FDA Data Reveals Uptick in Foreign Medical Device Inspections, Decrease in Warning Letters
  • December 9, 2015
  • Law Firm: Loeb Loeb LLP - Los Angeles Office
  • The FDA released its 2014 data on inspectional observations and warning letter citations issued to medical device manufacturers, citing an increase in foreign inspections, particularly in China, as well as a decrease in overall warning letters sent to medical device manufacturers.

    The FDA's Center for Devices and Radiological Health released data on FDA Form 483 Observations and warning letter citations issued to medical device manufacturers in 2014, citing an increase in foreign quality system surveillance inspections and a decrease in warning letters.

    The "2014 Annual FDA Medical Device Quality System Data," which included data from Jan. 1, 2008, to Dec. 31, 2014, showed a jump in foreign inspections from 460 in 2013 to 594 in 2014, coinciding with a decrease in domestic inspections from 1,741 to 1,619. China saw the most inspections, at 190, followed by Germany (72), Japan (37), Taiwan (29) and Switzerland (25). The U.S.'s neighbor to the north, Canada, saw 24 inspections in 2014.

    Voluntary action was required in slightly more foreign inspections than domestic inspections, at 43% compared with 40%. Similarly, official action was taken in 15% of foreign inspections, but only 8% of domestic inspections.

    The agency found that 58% of foreign-based device manufacturers were not fully compliant with the Quality System Regulation, compared with 48% of domestic manufacturers. Corrective and preventive action (CAPA) violations and production and process controls (P&PC) were the top areas cited by the agency. In 2014, P&PC violations were cited in 1,197 inspectional observations, up from 1,151 in 2013. CAPA violations were cited in 1,148 inspectional observations, compared with 1,085 the prior year. P&PC made up 32% of 483 observations, while CAPA made up 31%.

    The 2014 data also showed a decrease in warning letters, from 144 in 2013 to 121 in 2014. These included 21 CFR 820 (Quality System Regulation) deficiencies. In contrast to the uptick in foreign inspections, domestic manufacturers saw an increase in warning letters, while foreign companies received fewer warning letters in 2014. Foreign companies received 45 warning letters in 2014, compared to 74 in 2013, while domestic manufacturers saw 76 in 2014, up from 70 in 2013.