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

Source: https://www.keypedia.com/records/483/central-glass-co-ltd/289c9e53-dfeb-4b0e-bff6-3f3a67f160ad

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

---

## Details

- Record Type: 483
- Company Name: Central Glass Co., Ltd.
- Inspection Date: 2023-09-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Central Glass Co., Ltd., an API manufacturer in Ube, Yamaguchi, Japan, received six observations during an FDA inspection from September 11-15, 2023. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory controls, unsuitable water specifications, unvalidated cleaning procedures, and a lack of formal change control for critical changes. These findings indicate a need for improved quality systems and process control.

## 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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1