# FDA 483 - International Chemical Entity Japan Co., Ltd. - September 05, 2025

Source: https://www.globalkeysolutions.net/records/483/international-chemical-entity-japan-co-ltd/b060dc73-a214-47b9-8f55-70ec178290f0

> FDA 483 for International Chemical Entity Japan Co., Ltd. on September 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Chemical Entity Japan Co., Ltd.
- Inspection Date: 2025-09-05
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2019-03-18](https://www.globalkeysolutions.net/records/483/international-chemical-entity-japan-co-ltd/79e481e7-6b6b-4dc7-a57b-07261d6c5cb6)

## Related Officers

- [Geoffrey Kiillii](https://www.globalkeysolutions.net/people/geoffrey-kiillii/7781cbb2-8de5-4fd4-b92f-560206c5d88e)
- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.globalkeysolutions.net/companies/international-chemical-entity-japan-co-ltd/2df2ae11-1140-4d29-86fd-eecb26da4bd9

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8