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Date Posted: 15:07:53 04/01/09 Wed
Author: Bob
Subject: forum

This from this morning's San Jose Mercury News: "The US Food and Drug Administration, with the impossible task of 'regulating' 18,000 makers of drug devices, has had virtually no increase in staff in 15 years. It's little wonder, then, that the AM2PAT company of Angler, N.C., was not caught before bacteria in its pre-filled syringes were linked to 5 deaths and hundreds of illnesses in December, 2007. Subsequently inspected, AM2PAT's saline and heparin syringes were found to contain 'debris' and 'sediment' and to be 'muddy'and 'dingy brown' in color. Furthermore, according to a February report in the Raleigh News & Observer, the required 'clean (air) room' was found to be just a room with a fan, and the company's 'chief microbiologist' was revealed to be a teenager who had dropped out of high school. The company's owner has fled to his native India."

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