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Thanks for the Warning Letter: Part I

small_cup_of_coffee

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.