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Deadly consequences of FDA's failure to shutdown tainted syringe manufacturer

The June 7, 2009 edition of the Chicago Tribune carried a long article discussing the consequences of the Food and Drug Administration's failure to shut down a contaminated plant operated by a syringe manufacturer now associated with four deaths and hundreds of illnesses.   The plant in North Carolina was inspected in July of 2007 by the FDA in response to reports of contamination with "red, brown and black particles."  She reported that the plant had a plan to respond to  the "rust contamination" and took no action beyond reporting that the plant had "switched to an unreliable sterilization method."

One week after her inspection, the FDA learned that a distributor of the syringes was recalling 1.3 million of the syringes.  Under FDA written policies, this should have resulted in a more thorough repeat inspection, however, FDA officials claim that they are so understaffed that this written policy is no longer followed.  Months later, after reports of injury, the FDA did perform a more thorough inspection, found a mess, and shut the plant down in January of 2008.  The owner has now fled the country and two other employees pleaded to fraud and were sentenced to several years in prison.  As the Tribune pointed out, however, this won't bring back the four people who died as a result of the FDA's inaction, including a 29-month old infant.

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