FDA

FDA creates Guidance on ISS/ISE Placement

This morning I saw that FDA put out an actual guidance on placement of the ISS/ISE.

FDA Inspections and the Dreaded 483

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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