Is someone aware of any artilce reviewing common problems with FDA inspections like 483 letters? Dr. Layloff talked about some common problems with regard to FDA 483 warning letters during AAPS 2002, but I haven't got a copy of his talk.
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By Anonymous on Monday, December 9, 2002 - 09:56 am:
Try this link:
http://www.accessdata.fda.gov/scripts/wlcfm/cindex.cfm
You can also look at the warning letters by subject, company, issue date. This will give you an idea of what they are looking at. It is amazing how some companies operate.
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By B.Buglio on Monday, December 9, 2002 - 12:33 pm:
'nother site: fda.gov/foi/warning.htm. Can search
within 6 catagories including above