Medical Devices Warning Letter Statistics 2011

The European Compliance Academy (ECA) annually provides an analysis of the FDA Warning Letters. Following you will find the 2002 to 2011 Warning Letters "Top Five" list with regard to medical devices - with the FDA fiscal year (October through September) as basis.

Compared to the year 2010 where the Center for Devices and Radiological Health (CDRH) issued 182 Warning Letters the number in 2011 (156 letters) is decreasing. In comparison to the years 2002-2009 it is still a lot higher, though. At a closer look the number of Warning Letters issued referring to Quality System Regulations (QSR) in 21 CFR 820 in 2011 decreased to 109, but this is again higher than in the previous year.

The first place goes to CAPA deficiencies - as in the years before. Design Controls comes in second, also like last year. Deficiencies relative to Complaint Files are in the 3rd place and have thus fallen back. New are Purchasing Controls on position 4, and place 5 goes to deficiencies regarding Process Validation (2010 in place 3) and the chapter 21 CFR 820.80 (Receiving, in-process, and finished device acceptance, 2010: Place 4).

Year Number WLs Top 1 Top 2 Top 3 Top 4 Top 5
2002 61 .100 .75 .198 .30 .70
2003 61 .100 .30 .198 .20 .80
2004 104 .100 .20 .22 .30 .80
2005 106 .100 .198 .80 .20 .22
2006 79 .100 .30 .198 .80 .75
2007 78 .30 .100 .198 .70/.80 .75
2008 91 .100 .198 .30 .20 .80
2009 84 .100 .198 .30 .20 .22
2010 182 .100/.198 .30 .75 .80 .20
2011 156 .100 .30 .198 .50 .75/.80

WLs: Warning Letters

The table only lists the rear part of the CFR identifcation

  • 21 CFR 820.20: Management responsibility
  • 21 CFR 820.22: Quality audit
  • 21 CFR 820.30: Design controls
  • 21 CFR 820.50: Purchasing controls
  • 21 CFR 820.70: Production and Process control21 CFR 820.75: Process validation
  • 21 CFR 820.80: Receiving, in-process, and finished device acceptance
  • 21 CFR 820.100: Corrective and preventive action
  • 21 CFR 820.198: Complaint files

Conclusion: Comparing the Medical Devices Warning Letters there is only little news in 2011. New in the Top Five are merely deficiencies with regard to paragraph 21 CFR 820.50 (Purchasing Controls). The other findings have partly been in the "Top Five List" for years.

Author:
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

PS. As participant of the ECA course "Medical Devices Validation Manager", in Heidelberg, Germany, from 18-19 January 2012 you will receive the detailed Warning Letters analysis as a free of charge "Medical Device Warning Letters CD".

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