FDA Inspectors Uncover Bacteria, Filth at McNeil Plant

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    FDA Inspectors Uncover Bacteria, Filth at McNeil Plant
    By Peggy Peck, Executive Editor, MedPage Today
    Published: May 05, 2010

    WASHINGTON — The wide-ranging recall of children’s cold and pain liquid medicines by McNeil Consumer Healthcare was triggered by problems — including bacterial contamination of raw materials — at the company’s plant in Fort Washington, Pa., according to an inspection report released by the FDA.

    The report states that “raw material [that had] known contamination with Gram negative organisms . . . were approved for use to manufacture several finished lots of Children’s and Infant’s Tylenol products.”

    But at a press briefing, Michael A. Chappell, the FDA’s acting associate commissioner for regulatory affairs, said there was no evidence of bacterial contamination in the finished products.

    Deborah M. Autor, director of the office of compliance at the FDA’s Center for Drug Evaluation and Research, said the possibility of harm from the recalled products was “remote” and urged caution in interpreting the FDA inspection report, calling it preliminary and incomplete.

    She said it was difficult to understand the full impact of the findings without an accompanying narrative, which was still being assembled.

    In response to the FDA, the company posted this statement on its website:

    “The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us and not indicative of how McNeil Consumer Healthcare intends to operate.

    “While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations and work diligently to ensure that they are addressed.”

    FDA Commissioner Margaret A. Hamburg, MD, said the take home message for physicians and parents is that the recalled products should not be used. She said that safe generic versions of the products are available. http://www.mcneilproductrecall.com/

    The inspection report details a number of other problems ranging from a lack of formal safety procedures to visible dirt in the plant. The Fort Washington plant has been shut down, and Autor declined to estimate how long it would take to bring the facility up to standard.

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