# FDA 483 - UBE Corporation - January 26, 2026

Source: https://www.globalkeysolutions.net/records/483/ube-corporation/10e695f6-7927-4b7b-9f26-ec7b665d3215

> FDA 483 for UBE Corporation on January 26, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UBE Corporation
- Inspection Date: 2026-01-26
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Ube API & Intermediates Factory, Ube Chemical Factory, an API manufacturer, revealed significant deficiencies in their quality control systems. Observations included an inadequate Out-of-Specification (OOS) procedure lacking scientific justification for retesting, incomplete and unverified laboratory records, and insufficient monitoring of water system micro attributes. These issues indicate a lack of robust controls over product quality and data integrity.

## Related Documents

- [483 - 2017-09-28](https://www.globalkeysolutions.net/records/483/ube-corporation/440cfa7a-07e2-4c2a-8ccb-fd97ea7068f8)

## Related Officers

- [Consumer Safety Officer (Investigator)](https://www.globalkeysolutions.net/people/torrance-slayton/4c696f8c-5d66-4465-aca4-e450e76eded9)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd