Immunomedics (IMMU) - moderated Message Board

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Biotech / Medical : Immunomedics (IMMU) - moderated

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JJINV

To: JJINV who wrote (49655)	1/23/2019 2:10:51 PM
From: MFG ENG	1 Recommendation of 63283

"My comments: The FDA is kind of beating a dead horse here. We know IMMU was not great at preventing contamination" I am not convinced anybody knows that. All conjecture at this point.. we have very little facts. The crucial word in my comment is "was". I KNOW IMMU was not great at preventing contamination as fact because the 483 told me so in clear words in at least 2 of their findings. You just have to be able to interpret the complaints the FDA had which I can because this is my life as a biomedical device manufacturing engineer. My hope is that Pehl and crew have turned this around and uncontrolled contamination will no longer be a specter in subsequent inspections by the FDA. Would really like to see the actually CRL, and a complete response by IMMU magmt. Me too because then I would know the scope of what remediations they are still on the hook for and can better guess at a completion time for that. Is there any way to request this information through the Freedom of Information Act? Sooner than later.

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