Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place

You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. How does the past fiscal year (01 October, 2017 - 30 September, 2018) look? And what changed compared to fiscal year 2017?

Evaluation of the "Top Three"

During the past fiscal year, the FDA issued fewer warning letters (24) than in the comparable period of 2017, seven of which were not related to GMP for medical devices (21 CFR 820, QSR). In the comparable period of 2017, there had been a number of overall 34 warning letters, out of which 28 had been related to 21 CFR 820.

The actual number of 17 warning letters makes a significant statistical evaluation of the Top Five deficiencies impossible. Therefore, the focus lies on the Top Three in this instance. Just like in the first half year, deficiencies related to "Design Controls" (21 CFR 30) come in first place. The second place is shared by deficiencies regarding "Complaint Files" (21 CFR 820.198) and deficiencies regarding "CAPA" (21 CFR 820.100), last of which has been the usual "frontrunner" in the past few years. Third place is taken by deficiencies related to "Production and Process Control" (21 CFR 820.70).

A comparison with previous years may be found in the following chart:

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
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 61 100 30 198 50 75
2017 34 100 198

30/80

70/90 75
2018 24 30 100/198

70

N/A N/A

WLs: Warning Letters

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

Bottom line: after the already low number of waring letters from the FDA in 2017, even fewer warning letters were issued during the past fiscal year. The Top Three findings remain comparable to the findings of previous years. However, CAPA has lost its top position this year and slipped down to second place.

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