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FDA inspection failed to catch tainted syringes

An investigation co-published by the Chicago Tribune and ProPublica reveals that the Food and Drug Administration failed to prevent the distribution of tainted syringes linked to several deaths and serious illnesses. "Three months before the pre-filled syringes were shipped in October 2007, an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust. The inspector did not note that the plant had switched to an unreliable sterilization method. A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product posed a reasonable probability of serious injuries or deaths."

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