Validation on Rank 3 in the FDA Warning Letter Statistic 2010 regarding Medical Devices

Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. In the following, you will find a ranking based on the evolution of the Top 5 deviations in the FDA Warning Letters (regarding Medical Devices) issued between the years 2002 and 2010 (year means here the FDA fiscal year beginning in October of the previous calendar year and ending in September of the current year).

182 Warning Letters were issued by the Centre for Devices and Radiological Health (CDRH) in 2010, a number which is much higher than in the years before. If we take a closer look, we can notice that "only" 91 Warning Letters have been addressed on Quality System Regulations (QSR), mentioned in 21 CFR 820. 

This time, the first place is shared between missing CAPA and deviations on Complaint-Files. Top 2 of the deviations is occupied by missing Design Controls, top 3 are deviations on Process Validation and place 4, deviations on 21 CFR 820.80. Place 5 is occupied by insufficient Management Responsibility.

Fiscal Year No. of WL 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

WL: Warning Letters.

The table only indicates the last 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 820.70: Production and Process control
21 CFR 820.75: Process validation
21 CFR 820.80: Receiving, in-process, and finished device acceptance
21 CFR 820.100: Corrective and preventive action
21 CFR 820.198: Complaint files

Conclusion: because of place 1 being occupied by two elements, Deviations on Design Controls ranks 2. Missing Process Validation is on place 3 - again in the Top 5 ranking, as well as deviations on 21 CFR 820.80. Compared to 2009, insufficient Management Responsibility dropped to rank 5.  

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

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