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# CDRH Quality System Inspections Declined Last Year
- URL: https://www.fdaweb.com/cdrh-quality-system-inspections-declined-last-year/
- Published: 2016-03-15T12:00:00.000Z
- Updated: 2026-09-15T02:44:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135078

> CDRH conducted 5% fewer device quality systems (QS) surveillance inspections last year, according to just-posted [inspection metrics](http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM490768.pdf?ref=fdaweb.com). 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.  
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> 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.