The FDA has posted the 2019 483 observations as an excel file. The FDA has made these files available every year since 2006 and I find them to be one of my favorite tools for evaluating regulatory trends.
So for example, looking at change related 483 I see:
Or for data integrity issues:
Very useful resource that should be in the bookmarks for every pharmaceutical quality professional.
2 thoughts on “FDA 483 data”