CONCEPT HEIDELBERG regularly evaluates the FDA warning letters. In the following, the development of the top 5 "hit list" of warning letters regarding medical devices from the years 2002 to 2009 is described. Here, the years are FDA's fiscal years (October of the previous year until September of the year in question).

After very high numbers of warning letters issued in the years 2004 (104) and 2005 (106) and somewhat lower numbers in 2007 (78) and in 2006 (79), the total number of 91 warning letters regarding medical devices sent out in 2008 was higher again. However, "only" 64 of the warning letters refer to the Quality System Regulations (QSR) in 21 CFR 820. For 2009, with 84 warning letters, the number is slightly higher than in 2006 and 2007. Here, again, only 64 of the 84 warning letters refer to the QSR. However, compared with 2008, (almost) nothing has changed in the order of the top 5. CAPA ranks 1st, closely followed by deficiencies in complaint files. Deviations regarding design controls and management responsibilities rank 3rd. What is new is that deficiencies in the quality audit now rank 5th.

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

Year	Number of 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

WLs: Warning Letters
The table only lists the right part of the CFR name.

• 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

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