Medical Devices Warning Letter Statistics 2012 - Rank 1 for CAPA and Complaint Files

The European Compliance Academy (ECA) annually provides an analysis of the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for fiscal year (FY) 2012 (from 1st October 2011 to 30 September 2012).

We've already drawn up an interim report of Medical Device Warning Letters for the first half of fiscal year 2012. Since then there have been a few changes. In the following, you will find comparisons with the previous fiscal years.

The number of Warning Letters issued by the Center for Devices and Radiological Health (CDRH) in fiscal year 2012 (181) is comparable to the number of letters issued in 2010 (182 Warning Letters) and thus considerably higher than in fiscal year 2011 (156). Among the 181 Warning Letters issued in fiscal year 2012, 147 refer to cGMP requirements for medical devices (Quality System Regulations (QSR)) in 21 CFR 820).

Under the Top 5, we've found "older acquaintances" and two "newbies". As often in recent years, the first place goes to CAPA deficiencies. This year though, CAPA deficiencies must share Rank 1 with Complaint Files as in 2010. Design Controls gets the second place like in 2010 and 2011. Place 3 goes to deviations from chapter 21 CFR 820.80 (Receiving, in-process, and finished device acceptance),  which is "better" than in 2011 with place 5. Purchasing Controls get place 4 as in the previous fiscal year. New: Deficiencies regarding Device History Records (21 CFR 820.184) and Nonconforming product (21 CFR 820.90) have now joined the Top 5 together.

The classification of the number of critised deficiencies regarding the "Subparts" of 21 CFR 820 is also interesting. Place 1 goes to the subpart "Records" (the many deficiencies relative to Complaint Files and now also Device History Records are significant for this subpart). Place 2 goes to the subpart "Production and Process Controls" (which also includes process validation). Place 3 goes to the subpart "CAPA". The subpart "Quality Systems Requirements" gets place 4 and "Design Controls" place 5. The following table compares the evolution in the previous years:

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
2012 181 .100/.198 .30 .80 .50 .90/.184

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 control
21 CFR 820.75: Process validation
21 CFR 820.80: Receiving, in-process, and finished device acceptance
21 CFR 820.90: Nonconforming product
21 CFR 820.100: Corrective and preventive action
21 CFR 820.184: Device History Record
21 CFR 820.198: Complaint files

Conclusion: The FDA Medical Devices Warning Letter statistics 2012 haven't really changed compared to 2011. What can be noticed is the high number of Warning Letters issued. The Top 5 are - as already mentioned - older acquaintances from the previous years. For the first time since 2002, place 5 went to Device History Record and Nonconforming product.

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