Japanese Drugmaker Draws FDA Warning for Repeat Offenses

August 24, 2018

Citing data integrity concerns, the FDA hit Kyowa Hakka Bio with a warning letter for repeat violations at its Hofu, Yamaguchi facility. The agency issued a previous warning to the facility in 2010.

The FDA said the API manufacturer used data or performed retesting after obtaining out-of-specification results. The facility also manipulated data to meet a system suitability test’s specifications for high-performance liquid chromatography (HPLC) analysis of raw material.

The firm blamed the event on a “lack of awareness or seriousness” of the good manufacturing deviations and an environment that allowed for easy manipulation of test data.

It claimed none of its distributed products were found to be OOS, but failed to provide any supporting data or details about corrective measures it implemented.

Additionally, the company failed to implement adequate controls for its HPLC systems to prevent unauthorized access or data tampering. Some systems lacked audit trail records or the capability to record them — and unique user names and password weren’t needed to access all of the systems. The firm said it didn’t require such security measures because it wanted operators to be able to continue work started by others.

The company also used unsecured Excel worksheets during annual performance evaluations of production data, such as process capability and standard deviation. The files had no change history and could be modified without authorization.

“Your firm’s lack of data control calls the reliability of your data into question,” the agency said.

The FDA ordered the firm to conduct a comprehensive investigation of its inaccurate data records and reporting, and provide a summary of all laboratories, manufacturing operations and systems to be assessed, a risk assessment of the data’s impact on drug products and a corrective action plan.

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