Daiichi Sankyo Co., Ltd. Hiratsuka Plant – FDA 483, Apr 21, 2026
An FDA inspection of Daiichi Sankyo Co., Ltd.'s Hiratsuka Plant revealed significant deficiencies in the manufacturing of sterile injectable drug products. Observations included failures in aseptic process controls, inadequate quality control unit procedures, and insufficient environmental monitoring. The inspection also cited issues with facility maintenance, visual inspection programs, smoke studies, and laboratory controls, indicating a broad range of non-compliance with good manufacturing practices.
ID · f63590c1-c14a-4664-b4bb-7c1ebb10e92c
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