Medical Devices Warning Letter Statistics 2015 - Process Validation again in the Top 5

In our News What is new with regard to Warning Letters for Medical Device Manufacturers? from 2 September 2015, we reported about statistics of the FDA from the first half year 2015 with regard to Warning Letters addressed to medical devices manufacturers. Below you will find out more about the current evolution of the top 5 list regarding medical devices for the complete fiscal year (FY) 2015 (1 October 2014 to 30 September 2015, as of 10 October 2015).

In the following information, you will find a specific comparison with the previous fiscal year 2014.

In fiscal year 2015, the Center for Devices and Radiological Health (CDRH) issued 95 Warning Letters which is comparable to the number of letters issued in fiscal year 2014 (98). Among the 95 Warning Letters issued in 2015, "only" 65 refer to cGMP requirements for medical devices (Quality System Regulations (QSR) in 21 CFR 820).  

As in the last 3 years, regular acquaintances rank the top 5: the first 3 places are occupied by the same deficiencies. CAPA deficiencies take the first place - as they already have since 2008. Deficiencies with regard to "Complaint Files" follow as No. 2 as in the last 2 years. Also comparable to the last 2 years, place 3 goes to deficiencies relative to "Design Controls". As in the previous year, deficiencies to "Purchasing Controls" arrived at place 4. For the first time since 2011, deficiencies regarding Process Validation (21.CFR 820.75) have come - once again - to place 5. 

It is also interesting to see is how the numbers of the criticised deficiencies are assigned to the various "subparts" of 21 CFR 820. Subpart M "Records" takes first place which is similar to fiscal year 2014, whereas the second place goes to Subpart "Production and Process Controls" (2014: place 3). This is significantly due to the deficiencies with regard to Process Validation. The subpart "CAPA" ranks place 3 (2014: place 2) followed by the subpart "Design Controls" on place 4 (2014: place 5). Lastly, Subpart "Quality Systems Requirements" dropped down to 5th place (2014: place 4).

The following table compares the evolution in the previous years:

Jahr Anzahl 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

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 nothing really new in the FDA Medical Devices Warning Letter Statistics of fiscal year 2015. The Top 3 have remained unchanged over the last 2 years. Place 4 is also similar to 2014. The only novelty is represented by the "new rise" of Process Validation in the Top 5.

PS: You can purchase the Medical Device Warning Letter CD to get a more detailed analysis for € 99,- on the ECA Website.

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