February 20, 2021

Common FDA warning letter observations in 2020

Last year was a bizarre year and, hopefully, one of a kind. Not only did Covid-19 affect our personal and professional lives, it also had a huge impact on regulatory inspections which were delayed or executed remotely. In this article I present the main result of a data analysis on pharmaceutical FDA warning letters of 2020. I used the same tools as presented in one of my earlier articles on FDA warning letters. As shown on the pie chart below […]