This FDA field visit warning/corrections letter to an Illinois pharmaceutical testing lab has been making the press. Really, do click through, and don't miss the section on non-pharmaceutical uses of the lab by a co-located micro-brewery. I mean, if that's not entrepreneurial, I don't know what is.
The whole letter is worth a read to get a sense of how long this lab has been non-compliant and still allowed to operate. Would they be regulated more strictly as a brewery?
Breweries and distilleries are subject to FDA inspection, though the states may play a role as well. And what if the brewery inspectors find a co-located pharmaceutical testing operation? Well, that letter should surely be forthcoming.
