27/28 April 2021
The ECA evaluates deficiencies regarding medical devices in FDA Warning Letters on a regular basis. Remarkable is the low number of Warning Letters to medical devices manufacturers in the first half of fiscal year 2017 (1 October 2016 through 31 March 2017). In this period there were only 11 - of which three actually did not refer to medical device GMPs (21 CFR 820, QSR). In the similar period 2016 there were 37 Warning Letters - of which 33 referred to 21 CFR 820.
Due to the low number a reasonable statistical analysis of the top 5 deficiencies is not possible. What can be said, though, is that deficiencies regarding CAPA (21 CFR 820.100) are on the first place again, closely followed by deficiencies regarding complaint files (21 CFR 820.198) on place 2. On the third place are deficiencies relative to 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
It will be interesting to see if this trend continues in the second half of the year. We'll keep you up to date.