A Japanese API maker told the FDA that it had a “lack of awareness of the seriousness” of its GMP violations after admitting to the agency that it had manipulated data during its API testing.
The confession, laid out in a recent FDA warning letter followed an inspection last year of the Kyowa Hakko Bio manufacturing plant in Yamaguchi, Japan. During the inspection, managers acknowledged that workers manipulated data to get passing results after obtaining out-of-specification (OOS) or other unacceptable results during testing.
It also acknowledged the plant had an “environment where test data could be easily manipulated.” The inspector also cited the plant for not having individual passwords on its computers or an audit trail that would allow the company to know what employees manipulated data.
Some of these practices were not new to Kyowa Hakko, whose website indicates its parent is Kyowa Hakko Kirin. The FDA pointed out the plant had received an earlier warning letter and that inspectors also found similar issues during an inspection of the company’s site in Ube last year.
“These repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate. Your executive management remains responsible for fully resolving all deficiencies, and ensuring ongoing CGMP compliance,” the FDA pointed out in the warning letter.
The FDA told the company it wanted a comprehensive, independent review of controls and procedures for electronic data generated from all of its laboratory equipment. Based on that review, it told the company to provide a detailed CAPA to fix the laboratory systems.
Just a few weeks ago, the FDA posted a warning letter for another Japanese API maker. The agency slapped Yuki Gosei Kogyo with a warning letter, citing the Tokyo-based company for failing to report lab testing data on released lots.