FDA warns Steris Isomedix on QA, data manipulation issues

June 4, 2014 by Arezu Sarvestani

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.

FDA warns Steris Isomedix on QA issues

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.

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