PDA Letter Article

Thanks for the Warning Letter: Part II

by Steven Lynn, Lynn Consulting

World Management

5 Focus Areas for the C-Suite

[Editor’s Note: Part I appeared in the November/December issue .]

In my old U.S. FDA role, I would see companies terminate multiple quality and manufacturing heads shortly after receiving a warning letter and profess this action a big part of their overall remediation solution. But the CEO always remained unchanged. Why? While some of the terminations may have truly been warranted, I find it hard to believe that this was the case in every organization, especially since the CEO and his C-suite reports were never touched.