FDA Warning Letter Statistics for the Fiscal Year 2016 - CAPA still on Place 1

The news on the Medical Devices Warning Letter Statistics 2015 - What the FDA criticizes at Medical Device Manufacturers from 2 December 2015 already reported about the FDA statistics from 2015 respectively about the Warning Letters Medical Device Manufacturers received. Following you will find the latest developments - with regard to medical devices - in the top 5 list for the fiscal year (FY) 2016 (1 October 2015 to 30 September 2016, as of 3 October 2016). It specifically covers a comparison with the previous fiscal year 2015.

The number of Warning Letters the Center for Devices and Radiological Health (CDRH) issued in the fiscal year 2016 - 59 compared to 95 in 2015 - is clearly lower. However, from these 59 Warning Letters "only" 54 refer to cGMP regulations concerning Medical Devices (Quality System Regulations (QSR) in 21 CFR 820).

Comparable to the last three years, among the top 5 the same deficiencies are on positions 1-3. CAPA deficiencies take the first place - as they already have since 2008. On 2nd place are deficiencies with regard to "Design Controls", which is comparable to the years 2010-2013. "Complaint Files" slipped to 3rd place. Compared to 2015 they changed places with deficiencies relative to "Design Controls". "Purchasing Controls" ranked on place 4 - like the year before, and in position 5 one can find deficiencies regarding "Process Validation".

Also interesting is the country specific distribution of the Warning Letters in the fiscal year 2016 (data from 2015 are not available). From the total of 54 Warning Letters issued due to GMP deficiencies, 17 were addressed to European companies, 9 to Asian companies (China, Taiwan and Japan). From the 17 Warning Letters to European companies 7 came from UK, 4 from Germany, 2 each from France and from Italy and 1 each from Hungary and Greece.

Please see the table for a detailed comparison - as 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
2013 199 .100 .198 .30 .80 .50
2014 98 .100 .198 .30 .50 .80
2015 95 .100 .198 .30 .50 .75
2016 59 .100 .30 .198 .50 .75

WLs: Warning Letters

The table only lists the rear part of the CFR identification.
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 820.90: Nonconforming product
21 CFR 820.100: Corrective and preventive action
21 CFR 820.184: Device History Record
21 CFR 820.198: Complaint files

Conclusion
There is only little new in the FDA Medical Devices Warning Letter Statistics from the fiscal year 2016. The top 5 are comparable to 2015, only place 3 2015 ("Design Control") now changed places with deficiencies with regard to "Complaint Files".

The detailed analysis will be available as Medical Device Warning Letter CD free of charge at the ECA course "GMP for Medical Devices" from 13-14 October in Berlin, Germany.

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