Medical Devices Warning Letters Statistics for Fiscal Year 2019 - CAPA again "Front-Runner"

We regularly analyse the deficiencies identified in FDA Warning Letters relating to medical products. The title for the analysis of the last fiscal year 2018 was: "Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place".

Now, what is the situation for Fiscal Year 2019 (1 October 2018 - 30 September 2019)? A simple answer could be: CAPA is back in first place.

Analysis of the "Top Three"

By comparison with the last fiscal year, the total number of Warning Letters issued in 2019 was 26, with eight of these 26 Warning Letters not referring to Medical Device GMP (21 CFR 820, QSR). In the comparable period in 2018, there were a total of 24 Warning Letters, of which 17 related to 21 CFR 820.

Even with de facto 18 Warning Letters, a truly meaningful statistical evaluation of the top 5 deficiencies is difficult. Therefore, this time the focus is again on the top 3 deficiencies. In Fiscal Year 2019, the long-time leader "CAPA" (21 CFR 820.100) comes in first place again, followed by last year's No. 1 "Design Controls" (21 CFR 30) in second place. This second place is shared between the design deficiencies with deficiencies on "Purchasing Controls" (21 CFR 820.50) and deficiencies on process validation (21 CFR 820.75). In 3rd place come deficiencies for "Complaint Files" (21 CFR 820.198).

A detailed 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
2019 26 100 30/50/75

198

N/A N/A

WLs: Warning Letters

The table shows only the rear part of the CFR marking:

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: The Top 3 Findings are comparable to the "Findings" of the last fiscal years. However, compared to last year, CAPA again occupies first place this year.

PS: Participants of the GMP for Medical Devices conference, 13-14 October 2020 in Heidelberg will receive the FDA Medical Device Warning Letter Navigator on a USB stick. In addition to the FDA guidelines relevant to medical devices with a focus on quality, the stick also contains all FDA Warning Letters of recent years relevant for medical devices with statistical evaluations.

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