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

Source: https://www.globalkeysolutions.net/records/483/sumitomo-osaka-cement-coltd/7edd29a5-3a0e-40b6-b5a9-2ad9bed1df22

> 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: Office of Biological Products Operations - Division I
- Summary: Sumitomo Osaka Cement Co., Ltd., an API manufacturer in Osaka, Japan, received a Form 483 citing significant deficiencies in its quality systems. Issues include an inadequate cleaning validation program, deficient Out of Specification (OOS) investigations lacking corrective and preventive actions (CAPA), and failure to establish the reliability of component supplier analyses. Furthermore, the quality unit did not fully adhere to its responsibilities, and audit trail reviews for analytical data were found to be inadequate, indicating a critical data integrity gap.

## Related Officers

- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1