Medical Devices Warning Letters Report 2007 - Process Validation Again among the Top 5

GMP News
30 January 2008
 

Medical Devices Warning Letters Report 2007 –
Process Validation Again among the Top 5

 
Concept Heidelberg regularly evaluates the FDA warning letters. The following text describes the development of the top 5 list of deficiencies regarding medical devices mentioned in warning letters issued between 2002 and 2007. In the context of this evaluation, year means "FDA fiscal year" (October of the previous year until September of the year mentioned).

After very high numbers of warning letters in the years 2004 (104) and 2005 (106), the total number issued in 2007 (78) can be compared to that of 2006 (79), but is still higher than in 2002 and 2003 (61 each).

Within the top 5, for the first time in years the deficiencies concerning CAPA were relegated to second place by the new "front runner" design controls. The following ranks are occupied by the usual suspects. Like in 2006, process validation ranks fifth. While it ranked as high as 2nd in 2002, it slipped down to rank 8 in 2003 and rank 9 in 2004, slowly rising again to rank 7 in 2005.

The following table gives an overview of the top 5 deficiencies:
 

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
 
WLs: Warning Letters
The table gives only the last few digits of the CFR reference.

• 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
 

A broad range of validation activities is covered by the ECA course The Validation Manager to be held from 5 to 7 March 2008 in Heidelberg.

 
Author:
Sven Pommeranz
On behalf of the European Compliance Academy (ECA)
 

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