483
International Chemical Entity Japan Co., Ltd.International Chemical Entity Japan Co., Ltd. – FDA 483, Sep 5, 2025
Record Details
An FDA inspection of International Chemical Entity Japan Co., Ltd., an API manufacturer in Iwaki, Fukushima, Japan, revealed two significant observations. The firm failed to establish scientifically sound procedures for identifying microorganisms in environmental and water samples and did not use validated, stability-indicating test procedures, specifically omitting forced degradation studies. These deficiencies undermine product quality assurance and patient safety.
- Inspection date
- September 5, 2025
- Product type
- drugs
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ID · b060dc73-a214-47b9-8f55-70ec178290f0
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