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FDA: Foreign Device Inspections on the Rise

Posted 17 March 2016 | By Michael Mezher 

FDA: Foreign Device Inspections on the Rise

Newly released data shows the US Food and Drug Administration (FDA) conducted fewer medical device quality systems inspections in 2015 compared to recent years, while the number of foreign inspections increased to their highest number in a single year.

In total, FDA conducted 2,104 inspections in 2015, down from 2,213 in 2014, approximately five to seven percent fewer than it conducted between 2011 and 2014.

Quality Systems Inspections, 2008-2015 (Source: FDA)

Annual Inspections2

Nearly 30% of the agency's 2015 inspections were outside the US, with China, Germany, and Japan once again seeing the most foreign inspections. Notably, both Canada and the UK moved up the list, from 6th and 9th to 4th and 5th, respectively.

FDA Top Foreign Inspections 2014-2015
Germany72 90

While the number of Form 483s and observations dropped slightly from 2014, the proportion of inspections that resulted in observations reached its highest point since 2008.

In 2015, FDA says it issued 924 Form 483s after medical device inspections, which account for more than 3,500 individual observations. Of the inspections, 11% resulted in 483s citing significant objections (official action indicated (OAI)) and 43 percent citing minor objections (voluntary action indicated (VAI)). For the first time since 2008, less than half of FDA's quality systems inspections yielded no objections (no action indicated (NAI)).

Quality System Inspections, 2008-2015 (Source: FDA)

Inspection Outcomes2

Foreign manufacturers were also more likely to be cited for serious observations than domestic manufacturers. Only 10% of domestic inspections resulted in citations for serious observations (OAI), whereas 15% of foreign inspections did.

Observations for corrective and preventative action (CAPA) and production and process controls (P&PC) issues each accounted for nearly one third of all observations, which is consistent with previous years.

Though the number of 483s decreased in 2015, the number of warning letters issued remained the same as the previous year at 121, with nearly half (59) going to foreign firms.


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