FDA knew of problems at plant that made tainted alcohol wipes;
Documents show sterilization issues as early as 2009; dozens may have been sickened.
The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm.
Since msnbc.com reported Feb. 15 about the death of Harrison Kothari , who was infected with the same type of rare bacteria that sparked the recall of tens of millions of pads and swabs, dozens of people have stepped forward to say they may have been sickened, too.
At the same time, government documents obtained by msnbc.com showed that federal Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there's no record that the FDA sent warning letters typically used to force firms to comply.
Due to improper sterilization, there have been skin infections, serious complications requiring surgery, abnormal pap smear results tied to the lubricating jelly, and death.
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