6/7 February 2024
We regularly analyse the deficiencies identified in FDA Warning Letters relating to medical products. Since medical devices can also be part of a combination product of a medicinal product and a medical device (in the USA even other combination possibilities exist), these statistics are also of interest for manufacturers of these products.
In the comparable period of fiscal years 2017 - 2022 (respectively from 1st October to 30th September), we mentioned the relatively low number of Warning Letters. The same is evident in fiscal year 2023 (1st October 2022 to 30th September 2023). An explanation of what this might be due to is provided in the conclusion.
In fiscal year 2023, the number of Warning Letters was slightly higher (24) than the comparable period in 2017 (11), 2018 (18), 2019 (13), 2020 (21), and 2021 (16), 2022 (17). Whereas, four of these 24 Warning Letters were not related to medical device GMP (21 CFR 820, QSR) either. Generally not included were Warning Letters on misbranded and adulterated products with respect to Covid-19.
With de facto 20 Warning Letters, a truly meaningful statistical evaluation of the top 5 deficiencies is difficult, which is why, as in previous years, the focus this time is once again on the top 3 deficiencies. Due to the relatively low numbers, there are also some duplications. First place is taken by deficiencies relating to "Design Controls" (21 CFR 820.30) and "CAPA (21 CFR 211.100)". Second place is shared by deficiencies relating to process validation (21 CFR 820.75) and "Complaints" (21 CFR 820.198). In third place are deficiencies relating to "Purchasing Controls" (21 CFR 820.50).
Due to the relatively small number of Warning Letters, a wide-ranging list of deficiencies is hardly possible. However, the top 3 are "old acquaintances" as "findings" of the FDA. CAPA, which has been the frontrunner for many years, also takes the leading position in fiscal year 2023, together with deficiencies relating to "Design Controls" (21 CFR 820.30). Design deficiencies have also been in the top 3 in recent years, as have deficiencies relating to Complaint Files (21 CFR 820.198) and Process Validation (21 CFR 820.75). Both deficiencies were frequently in the top 3 and top 5 in the past. Deficiencies relating to "Purchasing Controls" (3rd place) were also frequently in the top 5 in the past.
Why have there been fewer Warning Letters issued for years? In the mid-2010s, the number was still around 100 in some cases. Has the medical device industry become so much better in recent years? Perhaps yes, but the integrative approach that the FDA has been offering for some time following an inspection is probably also taking effect. What does that mean? The FDA reacts directly to the response letter that the inspected company sends to the FDA following a 483 notice of deficiency and interacts with the companies. In return, it issues fewer Warning Letters. However, these Warning Letters still show comparable "findings" as in the 2010s.
Participants of the live online training course "GMP for Medical Devices" on 21/22 November 2023 will receive the Medical Device Warning Letter Navigator with all Warning Letters issued to medical device manufacturers and their statistical evaluation since 2002.