# FDA 483 - Shanghai Kyowa Amino Acid Co., Ltd. - December 11, 2023

Source: https://www.globalkeysolutions.net/records/483/shanghai-kyowa-amino-acid-co-ltd/a9218305-01ca-4f9b-b289-370156d41f86

> FDA 483 for Shanghai Kyowa Amino Acid Co., Ltd. on December 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Kyowa Amino Acid Co., Ltd.
- Inspection Date: 2023-12-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shanghai Kyowa Amino Acid Co., Ltd. received an FDA Form 483 with one repeat observation during an inspection of its API manufacturing facility in Shanghai, China. The observation cited the firm for failing to follow its written production and process control procedures. Specifically, the firm did not initiate deviation investigations for observed corrosion and rust in manufacturing tanks, despite its own SOP requiring such actions.

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.globalkeysolutions.net/companies/shanghai-kyowa-amino-acid-co-ltd/597fd21a-b509-43d8-bbec-88c4fdcccbf7

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