2015 Annual FDA Medical Device Quality System Data

The United States Food and Drug Administration (FDA), the Center for Devices and Radiological Health (CDRH) (collectively CDRH) has issued 121 warning letters (WLs) for the calendar year (CY) 2015, the number remained the same from CY 2014 at 121 WLs.

The following provides key findings reported by the FDA/CDRH for CY 2015 in comparison with other years.  The summary report is downloadable in PDF.

Inspections, FDA Form 483 Observations, and Warning Letter Citations

In support of the FDA’s Transparency and Case for Quality Initiatives, the CDRH is providing data on inspections, inspectional observations, and Warning Letter (WL) citations issued in 2015.

FDA believes that this information will:

  • Help industry improve device quality by sharing common observations from inspections
  • Identify possible areas of emerging concern
  • Possibly help firms avoid receiving WLs

FDA Medical Device Inspection Data

  • Source of data – FDA’s Field Accomplishment and Compliance Tracking System (FACTS)
  • Timeframe January 1, 2015 – December 31, 2015
  • 2,104 FDA medical device inspections (domestic/foreign)

1067-FDA Medical Device QS Surveillance Inspections

Key Findings CY2015

  • The overall number of QS surveillance inspections decreased slightly from CY2014 to CY2015.
  • The number of foreign QS surveillance inspections continues to increase. Foreign inspections increased from 594 in CY2014 to 620 in CY2015. The agency has been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly.
  • Production and Process Controls and Corrective and Preventive Actions continue to be the most frequently cited QS subsystems.
  • The number of Warning Letters (WL) remained exactly the same from CY2014 to CY2015 at 121 WLs.

Download FDA Powerpoint Summary Report

Download “2015 Medical Device Quality System Data” UCM490768.pdf – Downloaded 117 times – 234 KB

Last Updated: 2016-03-16

Medical Device Quality System Data for Surveillance Inspections 2015
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