Updated; FDA admits weak oversight in tainted wipes review

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Updated; FDA admits weak oversight in tainted wipes review

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FDA admits weak oversight in tainted wipes review

Federal Food and Drug Administration officials have admitted to U.S. senators that they should have taken stronger action to stop a Wisconsin firm from making and distributing medical products potentially tainted with life-threatening bacteria . The contaminated products have been blamed in lawsuits for serious infections and the death of a 2-year-old child.

Instead of simply holding a meeting last August with officials from H & P Industries Inc. and the Triad Group of Hartland, Wis., the FDA should have followed two worrisome inspections and the regulatory session with a formal warning letter, an enforcement action that requires prompt and thorough response, said Jeanne Ireland, the FDA's assistant commissioner for legislation.

Such a letter would have served to "reinforce FDA concerns about GMP [good manufacturing practice] deviations," Ireland said in a letter sent late Thursday to Sen. Bennet, D-Colo., and Sen. Lamar , R-Tenn. The letter followed an "internal retrospective review" of the agency's oversight of the company, she wrote. .. continue reading...

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