# FDA 483 - Sakai Chemical Industry Co., Ltd. - November 17, 2023

Source: https://www.keypedia.com/records/483/sakai-chemical-industry-co-ltd/fdd1be48-5803-4327-97c8-f66210f99e47

> FDA 483 for Sakai Chemical Industry Co., Ltd. on November 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sakai Chemical Industry Co., Ltd.
- Inspection Date: 2023-11-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sakai Chemical Industry Co., Ltd. in Iwaki, Japan, revealed significant deficiencies in their Quality Unit's operations. The firm failed to adequately investigate laboratory errors and out-of-specification results, and did not properly justify changes to test specifications. Additionally, required change control procedures were not initiated for these critical changes.

## Related Officers

- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)

Company: https://www.keypedia.com/companies/sakai-chemical-industry-co-ltd/672049a3-e8ad-422a-a6fb-e443f02f110e

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