Medical Devices Warning Letters Statistics for the first half of Fiscal Year 2019

Recommendation

2/3 May 2024

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In both years 2017 and 2018 (period from October 1 to September 30), we reported a noticeably low number of Warning Letters. This trend has been observed to continue in the first half of Fiscal Year 2019 (October 1, 2018 - March 31, 2019). The following is an evaluation of the Top Three findings. 

In this six-month period, the number of Warning Letters (13) lay within the range between the figures for the comparable period 2017 (11) and 2018 (18). However, three of these 13 Warning Letters did not refer to Medical Device GMP (21 CFR 820, QSR).

Half-year statistics for Fiscal Year 2019

With de facto 10 Warning Letters, it is hardly possible to make a really meaningful statistical evaluation of the Top five deficiencies, which is why this time the focus is on the Top three deficiencies. As in the past, deficiencies regarding CAPA (21 CFR 820.100) are ranked first, followed by deficiencies regarding Design Controls (21 CFR 820.30), Purchasing Controls (21 CFR 820.50), Process Validation (21 CFR 820.75) and Complaint Files (21 CFR 820.198) on second. Three paragraphes share the 3rd place. These are deficiencies on Management Responsibility (21 CFR 820.20), Production and Process Controls (21 CFR 820.70) and Receiving, in-process, and finished device acceptance (21 CFR 820.80).

Conclusion

In the years prior to 2017, the number of Warning Letters was sometimes higher than 100 over the entire fiscal year. Does this mean that the industry has been improving in recent years and the FDA discovers fewer deficiencies? Not necessarily. This is the point where the integrative approach that the FDA has been offering for some time after an inspection comes in. What does that mean? The FDA reacts directly to the reply letter that the inspected company sends to the FDA in response to a 483-Form and interacts with the company. In return, fewer Warning Letters are issued.  It remains to be seen whether this trend will continue in the second half of the year. We will keep you up to date.