Kyowa Kirin warned by FDA over repeated manufacturing failures

Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) has been sent a warning letter by the US Food and Drug Administration (FDA) over issues at its manufacturing plant in Hofu-shi, Yamaguchi, Japan.

The FDA visited the facility in September last year and found ‘significant deviations from current good manufacturing practice (CGMP)’, according to the letter.

Among the deviations was the finding that some data had been manipulated to meet system suitability test specification, with the company admitting to the FDA that there was an environment where test data could easily be manipulated but failing to give evidence of corrective measures, the letter adds.