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After news broke this week about a North Carolina factory tied to bacteria-tainted syringes that killed five patients, criminal investigators revealed a telling fact: The company’s “chief microbiologist” was a teenage high school dropout. This week, two former employees of the AM2PAT manufacturing center in Angier, N.C., pleaded guilty in federal court to charges related to falsifying documents and shipping bacteria-tainted syringes full of blood thinners meant for patients receiving intravenous fluids.
Authorities are still seeking the company’s owner, who will face a 10-count indictment. In addition to the deaths, more than 200 people were sickened by contaminated syringes. The case raises a glaring question: As this biological tragedy was taking shape, where was the agency charged with standing between Americans and deadly medicine?
The Food and Drug Administration, it turns out, was aware of problems at the 40-employee lab as early as 2005. According to a letter it released Wednesday to ProPublica and the Raleigh News & Observer, the FDA warned the company in August of 2005 about “serious violations” and ordered the firm to change its practices. During a June 2005 inspection of the company, the FDA found nine “significant [quality] violations,” the letter says.
The company failed to conduct routine tests on its syringe-filling machine. The daily log of the “clean room” was only filled out once a month, the letter states. The company’s complaint-response system was in disarray. And employees were not properly trained: One was chewing gum while filling syringes; another was “improperly gowning” during sterility tests.
FYI.
President Obama certainly has his work cut out in front of him.
He’s trying to get the country to soar like Eagles and find himself to have inherited a turkeys placed in position of power by Bush and cronies.
The picture is a good one
There have been asswipes and idiots working for government and I really doubt that more were hired by the Bush admin than any other admin R or D or that will be hired under to O admin. It sort of goes with government employment.
All I can say is we definitely do not want more government. Not just because their stupid and misspend funds. But they don’t do what they are supposed to do. The SEC is another example of a government entity that fails to do what its designed to do. What is more regulation going to do if the agency does not follow its guidance.
#2, GigG: Ha, ha! Oh so true! I just left a Gov’t worker’s office where a 10 minute job took an hour to complete because the dim bulb that was serving me had just come back from vacation and had forgotten her network password. I’ll bet she puts a Post-it on her monitor before she leaves next time!
#3 jescott418 — so you don’t like government? Hey, let’s get rid of the FDA completely then! Let those nice syringe-making companies do whatever they want without burdensome government regulation, without silly rules about cleanliness and proper training. Gosh, things would be a lot better then.
Yeah, it worked so well on Wall Street.
# 5 Phydeau said, “so you don’t like government? Hey, let’s get rid of the FDA completely then!”
Sounds good to me. Most gov agencies serve no useful purpose yet suck plenty of $ from citizens wallets.
Thanks for the troll perspective, Paddy-O. 🙂
That damn Bush!
#3 OK, so what do you propose then, since self-regulation gives us teenage dropout chief microbiologists, and birds shitting directly into the peanut butter vats?
More oversight will only lead to more inefficient bureaucracy and higher taxes.
What is needed is more accountability. Put the guilty in jail and throw away the key. As it stands now, all they need is a good lawyer to get nothing more than a slap on the wrist.
::sigh: -all part of the plan.
take some time and do background on the
decision makers at the FDA. -none of this
should be surprising..except, maybe, the timing of the story..
-s
The problem here isn’t that the FDA couldn’t do their job. It was that their supervisors wouldn’t allow the investigators to do their jobs.
Eff eff eff,
That second block quote should have been closed. It is not part of the original article.
Sorry for my sloppiness.
Funny how all this stuff started showing up after January 21, 2009. Obama must have looked through the pile of papers on his desk and said “you got to be kiddng me!”.
I wonder how the Bushie supporters here will spin it, I relish the thought! (rubbing hands)