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Biotech / Medical : Immunomedics (IMMU) - moderated

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To: li3511 who wrote (48036)12/11/2018 11:18:21 AM
From: erickerickson5 Recommendations  Read Replies (6) of 63283
 
"yes, we will do that—right away, sir,"

My wife and I built a house (ahem) 30 years ago that we did most of the work on. I vividly remember walking around behind the inspectors with a notepad saying similar to the above like a mantra.....

The guy who dug my septic field tipped me off about inspectors well with this story. One background bit; the "rough inspection" of a septic field is basically looking at a hole in the ground:

"I once saw a septic field go up by $6,000. The owner was giving the inspector grief during the rough inspection, telling him what he could and couldn't do. The inspector walked over to the field, looked over the edge, and said 'it's got to go down another 12 feet and be backfilled with sand'. Then walked over to his truck and drove away".

I didn't like the plumbing inspector (different person than the above), not a bad guy, just one of those people that rubbed me the wrong way. That said, he looked at the vent behind the tiles behind the bathroom wall and said "it passes code, but the way you have it condensation will form and leak behind the tile and you'll have to replace the wall sometime if you don't change it". "Yes sir! Thank you sir!". He saved me a significant cost down the line.

How does all that relate? Well, I hope and expect IMMU to bend over backwards not to antagonize the FDA. Whether any of the issues have real consequences (and we can only guess at this point, Li's point about whether the stockpiled material is still usable is germane), the proper response is to fix it and pass the next inspection. And I'd far rather have these kinds of issues fixed now than when they start selling.

I'd love to know how frequent form 483's are after an inspection. 5%? 95%? I have no idea. If it's at the higher end it's hard to fault management...
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