# FDA 483 - International Chemical Entity Japan Co., Ltd. - March 18, 2019

Source: https://www.globalkeysolutions.net/records/483/international-chemical-entity-japan-co-ltd/79e481e7-6b6b-4dc7-a57b-07261d6c5cb6

> FDA 483 for International Chemical Entity Japan Co., Ltd. on March 18, 2019. 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: 2019-03-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of API Corporation, an API manufacturer in Iwaki, Fukushima, Japan, revealed significant deficiencies in their laboratory controls. The firm failed to establish scientifically sound specifications and test procedures, leading to issues like unvalidated methods and unsecured analytical equipment. Additionally, the inspection found that complete electronic raw data from critical laboratory tests were not being maintained.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

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Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1