FDA 483 - Kyowa Kirin Co., Ltd.

Kyowa Hakko Kirin Co's drug substance manufacturing facility in Takasaki-shi, Gunma, Japan, was cited for several deficiencies during an FDA inspection. Observations included inadequate testing of critical materials, insufficient facility cleaning documentation, inappropriate bioburden limits for validation studies, and an inadequate out-of-specification investigation procedure. These issues indicate concerns with quality control and manufacturing practices.