Kyowa Kirin Co., Ltd. – FDA 483, Dec 3, 2018

Kyowa Hakko Kirin Co., a drug manufacturer in Takasaki-shi, Japan, received a Form 483 for multiple deficiencies observed during an FDA inspection. The findings highlight significant issues across quality control, production, and laboratory systems, indicating a need for improved written procedures, environmental monitoring, and robust investigation processes. The firm's practices were found to be inadequate in ensuring product quality and preventing contamination.