# FDA 483 - Central Glass Co., Ltd. - September 11, 2023

Source: https://www.keypedia.com/records/483/central-glass-co-ltd/1929e75e-c64f-4734-aa68-93fc96f33bfa

> FDA 483 for Central Glass Co., Ltd. on September 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Central Glass Co., Ltd.
- Inspection Date: 2023-09-11
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Central Glass Co., Ltd. in Ube, Japan, an API manufacturer, was cited for six observations during an FDA inspection from September 11-15, 2023. The inspection revealed significant deficiencies in laboratory controls, water specifications, cleaning validation, change control, process validation, and raw material receiving procedures. These issues indicate a lack of robust quality systems and control over critical manufacturing processes.

## Related Documents

- [483 - 2023-09-11](https://www.keypedia.com/records/483/central-glass-co-ltd/289c9e53-dfeb-4b0e-bff6-3f3a67f160ad)

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/central-glass-co-ltd/df9e20f9-4cd5-4ab6-b166-4216c0d628db

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3