FDA 483 Observations from 2020

Every year, PathWise compiles information on the top FDA 483 observations from the previous year’s inspection observations. 2020 was a year like no other, with the Coronavirus halting FDA inspections for a time. The results for the year show a drastic reduction in inspections overall, however the trends remain consistent with previous years in what the top 483 observations are, and what organizations generally struggle with. See what the common violations are so you know where to start improvement projects in your quality systems!