CDRH Quality System Inspections Declined Last Year

CDRH conducted 5% fewer device quality systems (QS) surveillance inspections last year, according to just-posted  inspection metrics. The Center conducted 2,104 QS inspections, which is 109 less than in 2014. More foreign inspections were performed in 2015 (620 inspections) than in 2014 (594), which translates to a 4% increase. This was offset by an 8% (135 less inspections) drop in domestic inspections — from 1,619 inspections in 2014 to 1,484 in 2015.


The metrics show that the number of  Warning Letters issued  remained exactly the same from 2014 to 2015 at 121, despite the drop in inspections conducted. Violative inspections surged 22%, they show, with “official action indicated” (OAI) classifications rising from 9% in 2014 to 11% in 2014. When broken down further, foreign inspections saw a 15% OAI rate, whereas domestic inspections were at 10%. During inspections, the most cited QS subsystems continue to be Production and Process Controls and Corrective and Preventive Actions.