February 2021

Your Fifteen Years of Fame. Part 1

What happens when your company gets a Warning Letter from FDA?  Let’s hope it never happens to you.  But we’re going to explore that possibility in this post.  Then we’ll discuss how you should respond to FDA by reviewing a recent Warning Letter that you can see at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allay-pharmaceuticals-llc-609023-01272021