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.

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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