FDA Inspections and the Dreaded 483

There is a nice brief discussion of what a 483 is (in case you are dying to know) at the path below, along with a link to some suggestions that FDA has put out there on how to respond to one if you get one.

http://www.eyeonfda.com/eye_on_fda/2009/02/fda-presentation-on-responses-to-483s.html