May 2020/1 - FDA Warning Letter Trend Results 2019

In this blog I would like to update you on the trends from the FDA Warning Letters that have been issued in 2019 for both finished Drug Products and Medical Devices. It is interesting to see that the total number of issued Drug Product related WLs has increased, whilst for the Medical Devices the number is as low as in 2018 (around 20). This is a huge reduction when compared to the figures of 2015 where the FDA issued more than 100 Medical Device related WLs. For further reading it is referred to the article in Science of Charles Piller “FDA enforcement actions plummet under Trump” of July 2nd, 2019 ( https://www.sciencemag.org/news/2019/07/exclusive-fda-enforcement-actions-plummet-under-trump ).

Fig.1 Trends Warning Letters 2019 – Finished Drug Products

Fig. 2 Trends Warning Letters 2019 – Medical Devices