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mr_sano

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mr_sano

Re: eagleagain2002 post# 25954

Wednesday, 09/08/2010 7:25:56 PM

Wednesday, September 08, 2010 7:25:56 PM

Post# of 59551
Why would the FDA audit a manufacturing or quality control system that is not setup? What is there to see? Deans place is a lab with some refurbishing capabilities and too many people on the payroll.

Now it does make sense for the FDA to review the actual device as it generate 3d imagery in real time. Thats a question I always wanted to know. Did the radiologist review the device while it was operating or did they just get files on a disk that Dean assembled. Could be a crucial distinction.
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