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Tue Nov 13, 2012, 11:10 PM

Leaking Clean-Room, Bird Flying Through Facility - Self-Regulation In Action At Compounding Center

From a leaking ceiling in the so-called "clean room" and a bird flying through a room where sterile drugs are packed to basic problems with contamination and failures to investigate patient harm, the sister firm of the pharmacy at the heart of the deadly fungal meningitis outbreak had serious flaws in its drug-making process, federal officials said Monday.

Food and Drug Administration officials found conditions at Ameridose LLC of Westborough, Mass., so alarming during the month-long inspection between Oct. 10 and Nov. 9 that the agency urged the company to recall all of its products on Oct. 31 because there was no guarantee they were sterile.

Ameridose is co-owned by Barry Cadden, the owner of the New England Compounding Center, the pharmacy blamed for fungal meningitis infections that have sickened 438 people in 19 states and caused 32 deaths. Cadden and his brother-in-law, Gregory Conigliaro, started both firms.

The new inspection included complaints of pregnant patients hemorrhaging after being given the labor-inducing drug oxytocin made by Ameridose, and reports of patients being over-sedated on the painkiller fentanyl -- or having no effect despite being given the maximum dose of a common children’s anesthesia drug, midazolam.

EDIT

http://vitals.nbcnews.com/_news/2012/11/12/15118098-fda-finds-bugs-bird-and-contamination-at-ameridose-plant

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Reply Leaking Clean-Room, Bird Flying Through Facility - Self-Regulation In Action At Compounding Center (Original post)
hatrack Nov 2012 OP
XemaSab Nov 2012 #1
hatrack Nov 2012 #2
XemaSab Nov 2012 #4
kestrel91316 Nov 2012 #3

Response to hatrack (Original post)

Tue Nov 13, 2012, 11:12 PM

1. Was it a Pakistani vulture?

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Response to XemaSab (Reply #1)

Tue Nov 13, 2012, 11:22 PM

2. Ah, if only!

BTW, you mentioned having Sillett for a professor . . . serious flake, or was he just going through a bad time at that time?

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Response to hatrack (Reply #2)

Wed Nov 14, 2012, 12:24 AM

4. He was having a bad time

*but* he's also kind of a jerk. He views it as his mission in life to weed out freshman from the natural sciences.

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Response to hatrack (Original post)

Wed Nov 14, 2012, 12:11 AM

3. How many homes does Mr. Cadden own, and how many millions does HE

have stashed in offshore tax havens? How much money did he make last year?

And more importantly, how much or little did he pay in income taxes?

I can just guess the answers, along with his political affiliation.

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