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.
"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.
"We have reviewed your responses and have determined that they are inadequate because the responses failed to identify actions to address the reasons why it took 3 discrete incidents of data manipulation/falsification and an FDA inspection to initiate a change in the quality system," according to the warning letter.
Some 2,900 records were also reportedly missing from the Dosimetry Measurement Application module, most of which was chalked up to deliberate deletion while others were deemed the result of a computer error.
Isomedix informed the FDA that it had made process changes, including implementing a new policy on re-reading dosimeters, but inspectors said that the company failed to provide proof or documentation of the changes.
The FDA also chided Isomedix for failing to properly warn customers who received products with potentially manipulated dosimetric data.
"On July 29, 2013 your firm’s Libertyville North facility initiated an investigation … into product runs that were overdosed and were subsequently made to appear within customer specification by employee data falsification and manipulation of dosimetric equipment," the FDA said. "This investigation identified approximately 89 runs as potentially affected. Your firm did not inform all of the identified customers that the dosimetric testing of their products may have been subject to falsification of dosimetric data."
Isomedix apparently made moves to inform customers of the situation, but the FDA maintained that the company hadn’t provided documentation proving that it had taken the appropriate steps.
Inspectors plan to conduct a follow-up investigation to check on some of the company’s new quality controls, the agency said.