PDA Letter Article

Thanks for the Warning Letter: Part I

by Steven Lynn, Lynn Consulting, LLC


When it Takes a Warning Letter to Spur Company Action

[Editor's Note: Part II appeared in the February 2019 issue.]

In the not-too-distant past, I was driving to downtown Washington, D.C. on a rainy morning in September. After fighting the tortuous traffic, I finally arrived at the PDA/FDA Joint Regulatory Conference. My first order of business? Find that life-sustaining cup of coffee. After checking in, I made a beeline to the coffee stand.