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.

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.

Steris spokesman Stephen Norton told MassDevice.com today that the company was taking steps to address all of the FDA's concerns and that Steris doesn't expect the inspection to have a material impact on the company's financial results.

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"Steris takes regulatory issues very seriously and are working diligently to remediate the concerns of the FDA," Norton told us. "The FDA notes nine items in the warning letter, which stemmed from a January, 2014 inspection of our Libertyville Isomedix facility. The concerns raised by the FDA are related to the processes and procedures at the facility. Since the inspection, Steris has provided detailed responses to the FDA regarding corrective actions taken, and is implementing a number of improvements to our systems."

The FDA investigation turned up 3 incidents since 2008 in which 5 employees at 3 different Isomedix facilities manipulated data regarding dosimetric testing. The FDA further cited instances of missing records, including some that were intentionally deleted. Steris' response to the FDA's concerns were deemed insufficient, the FDA said.