# FDA 483 - Sumitomo Chemical Co., Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/a472768a-0694-48ca-9d2d-564aeeef4a53

> FDA 483 for Sumitomo Chemical Co., Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumitomo Chemical Co., Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sumitomo Chemical Company, Limited, an API manufacturer in Ampachi-Gun, Japan, revealed two significant objectionable conditions. The firm's sampling procedures for raw materials were found to be non-representative, and inadequate controls were in place to prevent excessive access privileges to laboratory control records, raising concerns about data integrity.

## Related Documents

- [483 - 2016-09-20](https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/f014e97b-7130-4bc3-9a39-bd4194367cbf)
- [483 - 2019-09-06](https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/16a1e111-f5ee-4741-889d-4fed4a9f7437)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)

Company: https://www.globalkeysolutions.net/companies/sumitomo-chemical-co-ltd/3ce10d51-6999-467f-ac0e-cb6696a98aa5

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