# FDA 483 - Sumitomo Osaka Cement Co.,Ltd. - October 27, 2023

Source: https://www.keypedia.com/records/483/sumitomo-osaka-cement-coltd/25bf28e5-409d-4e67-9587-b50f3de7bd31

> FDA 483 for Sumitomo Osaka Cement Co.,Ltd. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumitomo Osaka Cement Co.,Ltd.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The inspection of Sumitomo Osaka Cement Co., Ltd. in Kaizuka-shi, Japan, an API manufacturer, revealed significant deficiencies across multiple quality system areas. These include inadequate cleaning validation, deficient Out-of-Specification (OOS) investigations without proper CAPA, unreliable supplier qualification, and a quality unit failing to fulfill its responsibilities. Furthermore, the firm's audit trail review for analytical data was found to be inadequate, indicating potential data integrity issues.

## Related Documents

- [483 - 2023-10-27](https://www.keypedia.com/records/483/sumitomo-osaka-cement-coltd/7edd29a5-3a0e-40b6-b5a9-2ad9bed1df22)

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Laila C. Mathew, Ph.D.](https://www.keypedia.com/people/laila-c-mathew-phd/8bcaf9fd-824d-4ab2-97df-bf6ff2564a3f)

Company: https://www.keypedia.com/companies/sumitomo-osaka-cement-coltd/b155539c-7ed7-44ed-85fb-25006860bc19

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c