The FDA 483: Just what is it?

The first article I wrote after leaving FDA was a clever little piece, reflecting my own unique style, on the Form FDA 483, Inspectional Observations. I wrote it in 2005 for the Immel Report which is edited by Barb Immel. Her website is on the Blogroll. I was looking it over and it still pretty much applies today except that Turbo EIR is much more commonplace. In fact, the primary obsolete fact is that I am no longer working for my former employer and my new e-mail is:

If you are interested in just what a 483 is, well then here you go.


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