483
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA 483, Jul 7, 2025
Record Details
An FDA inspection of Otsuka Pharmaceutical Co., Ltd. in Kanzaki-Gun, Saga, Japan, revealed significant deficiencies in their API manufacturing processes. The firm failed to ensure that test methods and specifications for a critical (b)(4) API reference standard were scientifically sound and appropriately validated. This included a lack of validation for the in-house reference standard and insufficient quality oversight during its manufacturing.
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ID · 65d3e912-60d3-4e10-ae9a-58f2210264b1
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