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FDA says San Diego stem cell company sold dangerous, unapproved products

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  • FDA says San Diego stem cell company sold dangerous, unapproved products

    San Diego Union-Tribune
    Dec. 22, 2018

    FDA says San Diego stem cell company sold dangerous, unapproved products

    by Bradley J. Fikes

    Twelve patients contracted serious infections after being given products supposedly containing stem cells from a San Diego company, the U.S. Food and Drug Administration said Thursday.

    The company, Genetech, is unrelated to Genentech, the large biotech company based in South San Francisco.

    The patients were all hospitalized for their infections. Most had been treated during August and September for orthopedic conditions such as pain and arthritis. Seven were treated in Texas, four in Florida and one in Arizona.

    The fecal bacteria E. coli and E. faecalis were detected by a Florida hospital in cultures taken from unopened Genetech products, according to a report from the Centers for Disease Control and Prevention.

    Earlier, a June FDA inspection found that Genetech was making products from umbilical cord blood that required FDA approval, the agency said in a Nov. 29 letter. It also found deficiencies in the company's manufacturing process.

    "These deviations pose a significant risk that the products may be contaminated with microorganisms or have other serious product quality defects," the FDA said.

    (see the rest of this story here):

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