# FDA 483 - UBE Corporation - September 28, 2017

Source: https://www.globalkeysolutions.net/records/483/ube-corporation/440cfa7a-07e2-4c2a-8ccb-fd97ea7068f8

> FDA 483 for UBE Corporation on September 28, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UBE Corporation
- Inspection Date: 2017-09-28
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of Ube Industries, Ltd. dba Ube API and Intermediates Factory in Ube, Japan, revealed significant deficiencies in their quality unit's oversight of cGMPs for active pharmaceutical ingredients. The firm failed to maintain electronic raw data, lacked adequate audit trails for laboratory instruments and manufacturing control systems, and had uncontrolled issuance of critical cGMP worksheets. These issues indicate a systemic breakdown in data integrity and quality management.

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## Related Officers

- [Senior Consumer Safety Officer ](https://www.globalkeysolutions.net/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)

Company: https://www.globalkeysolutions.net/companies/ube-corporation/76ca3dd5-0b44-4d3d-af9f-062d88ca7b3a

Office: https://www.globalkeysolutions.net/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591