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This story comes from my friend, Jeff Veyera*, my co-host on the ASQ podcast “The Fearless Workplace”. He tells it in his book “Culture is Everything”**.
Perhaps I should first explain what a steam explosion is. Then, the near destruction of my anticipated career might make some sense.
If you are in the drug, medical device, or dietary supplement industries and you do not follow Good Manufacturing Practices - GMPs, you can get in big trouble with FDA. That’s a bad place to be because FDA can:
Amazon has added new requirements for dietary supplement sellers on Amazon’s platform. These changes are alleged to provide additional assurance to consumers that the products marketed on its platform are safe and are manufactured and labeled in compliance with Food & Drug Administration (FDA) regulations.
Deming wrote his book, Out of Crisis, 40 years ago. Why is it still so hard to convince managers that they must drive fear out of the workplace? One problem is that managers, like all of us, are born into a culture of blame and most of them are never able to separate blame from accountability. This is the story that I tell new managers to explain the difference:
We are continuing our reviewing a recent FDA Warning Letter. This WL is such a rich tutorial on what not to do, we are devoting two blog posts to it. 
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 
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