Immunomedics (IMMU) - moderated Message Board

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Biotech / Medical : Immunomedics (IMMU) - moderated

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To: suite2321 who wrote (48083)	12/11/2018 10:49:32 PM
From: ladyPI	Read Replies (1) of 63285

I can go to the FDA, directly, and get the same info and know that what I am getting is legit. If FDA did not post the inspection report and/or response to it, how did these people get it? The FDA decides what reports get posts and make their own determination in that regard - unless they were required to give it to someone via a FOIA. I saw nothing on their site for immu to date - you can search by company name. So - I m curious how someone outside the FDA gets these. Idaho mentioned he has info it was via a FOIA request. If that were the case, FDA would have listed it on their site - I searched and did not find it. What we do know is that the 483 is not an unusual notice and gets used frequently. The top three reasons they are issued: procedure not written or fully followed; poor investigative failures; and absence of written procedures. Also of note is that the inspector lists items in order of importance. At this juncture, I am curious (after all, I am a PI) how some outside source got the notice. Why would anyone pay this company for a report they can get for free right from the FDA? What am I missing?

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