Wed Nov 14, 2012, 12:10 AM
hatrack (39,761 posts)
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.
4 replies, 799 views
Always highlight: 10 newest replies | Replies posted after I mark a forum
Replies to this discussion thread
Leaking Clean-Room, Bird Flying Through Facility - Self-Regulation In Action At Compounding Center (Original post)
Response to hatrack (Original post)
Wed Nov 14, 2012, 01:11 AM
kestrel91316 (51,279 posts)
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.