FDA Warns Steris Corporation-Isomedix On QA, Data Manipulation Issues

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FDA inspectors identify a handful of violations at Steris Isomedix's sterilization facility, including concerns that the company failed to respond appropriately to incidents in which employees were manipulating data. Steris's (NYSE:STE) Isomedix division is in the FDA's hotseat after inspectors turned up incidents in which employees faked data on testing for medical devices. The FDA this week unveiled a warning letter in which investigators chided Steris for failing to protect against data manipulation and for subsequently mishandling the incidents.

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