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US FDA warns GE Healthcare IT unit over records

Tue Aug 19, 2008 9:57am EDT

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WASHINGTON, Aug 19 (Reuters) - The U.S. Food and Drug Administration has warned GE Healthcare's Integrated IT Solutions unit for failing to keep proper records, according to documents released on Tuesday.

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The information technology unit, which makes various computer and software systems, also failed to establish proper procedures to review products, the FDA said in a warning letter dated Aug. 12.

GE Healthcare is a unit of General Electric Co (GE.N). A GE spokesman was not able to provide immediate comment on the letter. (Reporting by Susan Heavey, editing by Gerald E. McCormick)

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