Tag Archives: inspections

What’s the big deal with Form FDA 483s?

by Tony Chen

Okay, let’s settle this once and for all.  This week, we will be writing a series of posts that will give you an industry primer for what these Form FDA 483s are, why they’re important, how to avoid them, and how to respond to them.  Today, we cover the basics.  Some of you pros out there know this stuff all too well. Continue reading