18.10.2018

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

Ongoing/Continued Process Verification - Live Online Training

Recommendation

22/23 May 2024

Ongoing/Continued Process Verification - Live Online Training
from Control Strategy to Product Quality Review

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.