16/17 November 2021
The ECA regularly provides you with analyses of the deficiencies in FDA Warning Letters regarding medical devices. In the comparable period of the years 2017, 2018 and 2019 (1 October - 30 September), we mentioned the noticeably low number of Warning Letters. This trend is also evident for the first half of the fiscal year 2020 (1 October 2019 - 31 March 2020).
In this half year, the number of Warning Letters (15 ) was similar to those for the comparable period in 2017 (11), 2018 (18) and 2019 (13). However, one of these 15 Warning Letters did not refer to medical devices GMP (21 CFR 820, QSR). Warning Letters on misbranded and adulterated products with regard to Covid-19 were generally not included.
With de facto 14 Warning Letters, a really meaningful statistical analysis of the top 5 deficiencies is hardly possible, so that, as in recent years, the focus this time is also on the top 3 deficiencies. This time, defects concerning design controls take first place (21 CFR 820.30). Second place is shared by CAPA (21 CFR 820.100), Complaints (21 CFR 820.198) and Receiving, in-process, and finished device acceptance (21 CFR 820.80). In third place there are even four "candidates" with deficiencies in "Purchasing Controls" (21 CFR 820.50), "Production and Process Controls" (21 CFR 820.70), "Quality Audit" (21 CFR 820.22) and "Device History Record" (21 CFR 820.184).
Due to the small number of Warning Letters, it is hardly possible to list the defects. The design deficiencies alone clearly show up in 1st place. Before 2017, the number of Warning Letters for the entire fiscal year was in the 3-digit range in some cases. Why have fewer Warning Letters been issued in the past three years. Has the medical device industry improved in recent years? Maybe so, but the integrative approach that the FDA has been offering for some time after an inspection is probably also taking effect. What does that mean? The FDA responds directly and interacts with companies in response to the response letter that the inspected company sends to the FDA in response to a 483 deficiency report. In return, it issues fewer Warning Letters. It will be interesting to see if this trend continues in the second half of the year, as it has in the last three years. We will keep you up to date.
As a participant in the ECA Live Online Taining GMP for Medical Devices on 13/14 October 2020 you will get access to the Medical Device Warning Letter Navigator with a list of Warning Letters back to the year 2002.