FDA Sends Warning Letter to Kyowa Hakko Bio for Manipulating Testing Data

The FDA recently sent a warning letter to Kyowa Hakko Bio, the parent company of biosimilar developer Kyowa Kirin Biologics, in reference to an inspection of manufacturing plant, Hofu-shi, in Yamaguchi, Japan.

The inspection took place from September 4-8 of last year. The violations found by the FDA included, but were not limited to, failure of the quality department to ensure the active pharmaceutical ingredient manufactured at the facility was in compliance with current good manufacturing practices (CGMP), and failure to exercise controls over computer systems to prevent unauthorized access or changes to data.

In response to the inspection violations, Kyowa Hakko told the FDA that it had a “lack of awareness of the seriousness” of its GMP violations, after admitting that not only were “some data were manipulated to meet [system suitability test, SST] specification,” but that the plant itself had an “environment where test data could be easily manipulated.”

Additionally, the FDA explained that the computer systems at the plant did not have an audit trail capability including unique usernames and passwords required to perform high-performance liquid chromatography activities.

Kyowa Hakko went on to state that none of its products currently in distribution were found to be out of specification, though the FDA noted that the Kyowa Hakko “included no data to support this conclusion,” and that its “response is inadequate.”

According to the FDA, “You identified additional data integrity issues, but failed to provide details regarding the corrective measures your firm has implemented.”

Within its letter, the FDA also pointed out that a previous warning had been sent to another Kyowa Hakko plant at the Ube site that had similar CGMP violations. According to the FDA, the repeated violations demonstrate that executive management oversight and control over the drug manufacturing is inadequate.

Kyowa Hakko released a statement on its website acknowledging the receipt of the warning letter, as well as confirming that there “are no quality deficiencies in our products. At this time, we are not instructed to recall our products and/or suspend shipment due to this (warning letter).”

The FDA has required Kyowa Hakko to undertake steps to remediate the data integrity issues within the plant, including the launch of an investigation into the inaccuracies in data records and reporting, a risk assessment of the potential effects of the failures in the quality of drugs produced by the site, and a management strategy that encompasses the global corrective action and preventive action plan. Until the violations have been corrected and confirmed by the FDA, it may withhold approval of any new applications or supplements from the company.