FDA ignored complaints of filthy syringes from N.C. plant-5 dead, hundreds sick

[babylonsister]

FDA ignored debris in syringes

Complaints of filth came in 2005; plant's microbiologist was a teenage dropout
Sarah Avery and Sabina Vollmer - Staff Writers
Published: Wed, Feb. 25, 2009 05:19AM


RALEIGH -- Months before an Angier company shipped deadly bacteria-tainted drugs, the federal Food and Drug Administration received numerous complaints about sediment and debris in the medicine.

The FDA received reports about AM2PAT as early as 2005, but not until December 2007 did the agency issue recall notices to pull the drugs off the market.

AM2PAT, which is now the subject of a criminal investigation, sold tainted syringes of heparin and saline that have been linked to five deaths. At least 100 more people were sickened, often after receiving the medicines during chemotherapy, kidney dialysis and other intravenous procedures.

Two men pleaded guilty in U.S. District Court this week for their roles in the scheme, which involved falsifying documents to make it appear that proper sterility tests had been conducted. The company’s president, Dushyant Patel, faces 10 charges, but he has not been arrested. Authorities believe he fled to his native India.

Conditions at the plant, detailed in court documents and photographs, depict a facility in flagrant violation of proper manufacturing processes. Prosecutor Jason Cowley said the company’s “chief microbiologist” was a teenager who dropped out of high school. A key piece of laboratory equipment designed to catch evidence of contamination was broken, and another gauge was out of commission for a year. The so-called clean room, where air is carefully controlled to reduce the spread of germs, was ventilated with an ordinary room fan.

more...

http://www.newsobserver.com/news/health_science/story/1418047.html

Related:
http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=389&topic_id=5121161

[Mari333]

1. bastards..no oversight, no trained personnel, no union, typical

type of place that flourished during the bush admin. just like that peanut factory. this never ends.

[silverweb]

2. Unconscionable.

And how many more companies like this are there that just haven't come to light yet?

This is what deregulation has brought us.

My main beef with laissez-faire capitalism is that it is based on the premise that successful businesses are by definition ethical and supremely competent, that the "free market" would quickly put them out of business if they were not. That premise is false and the last 8 years have conclusively proven it.

[prolesunited]

3. Exactly

Corporations don't have a conscious. Their only job is to make money.

[babylonsister]

4. I am more angry at the FDA for ignoring this/not doing their job. nt

[silverweb]

6. And who has been in charge of the FDA?

Anti-regulation corporate toadies, that's who.

[beam me up scottie]

5. I worked for a company like this.

They didn't make medicine or syringes but they did make many of the parts on your motorcycles, cars and trucks.