Steris Corporation was warned by the FDA for several violations related to employee data manipulation and falsification.

The company’s Libertyville, Ill., facility opened an investigation in July 2013 to look into instances where product was overdosed but later made to appear within specification. However, the inspection fell short because it did not include a review of all potentially affected products, according to the May 22 warning letter posted recently online.

Steris also initiated local nonconformances for three instances of data manipulation at three separate facilities, but did not bump the issue to a corporate CAPA before the FDA’s inspection, the letter says. This would have allowed the company to address the issue across all STERIS Isomedix gamma irradiation facilities.

And while the company identified about 89 runs as possibly affected, it did not inform all identified customers that testing of their products may have been subject to data falsification, the letter adds.

The company, which sterilizes medical devices, did not adequately review its quality system in light of the data manipulation. The FDA notes that operators and material handlers were directly responsible for reading dosimeters that they placed on the product processing runs. “The analysis of the dosimeters is the primary quality control activity that determines the calculated dose for dosimeters in a gamma irradiation run and is the basis for product release,” the warning letter says.

Operators and material handlers report through operations personnel, but this created a conflict of interest when an employee reported that a run was overdosed and an operations team leader “provided guidance on how to falsify the absorbance readings so that they would appear to be within specification,” the letter says. “This reporting structure removes the Quality Unit from the ability to approve/reject irradiation runs based on dosimetry analysis and hinders the identification and correction of potential quality problems by the Quality Unit.”

The FDA said it would conduct a follow-up inspection to verify that Steris has implemented a revised procedure requiring a reading by a second independent operator.

The Oct. 29, 2013 to Jan. 8 inspection also identified 2,900 records that were missing from the main table of the company’s Dosimetry Measurement Application module between its installation at the facility on Nov. 4, 2011, and Nov. 6, 2013. “Each missing record represents an attempt at creating a dosimeter record,” the letter says, adding that “of the 2,900 missing records, 1,623 records/dosimeters … contained dosimetry data and were intentionally deleted from the DMA module.”

Other citations in the letter note that dosimeters are not routinely cleaned before analysis and an operator was seen putting an ungloved thumb on a dosimeter, thus introducing a fingerprint.

Steris has provided detailed responses to the FDA and is making improvements to the quality system at the Libertyville facility, spokesman Steve Norton said. The company does not believe the letter will have a material impact on financial results.

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