# FDA 483 - Ajinomoto Co. Inc (Kyushu Plant) - July 14, 2025

Source: https://www.keypedia.com/records/483/ajinomoto-co-inc-kyushu-plant/f92a6448-8bc1-4731-bcb2-b0c7f106d1d3

> FDA 483 for Ajinomoto Co. Inc (Kyushu Plant) on July 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Co. Inc (Kyushu Plant)
- Inspection Date: 2025-07-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Ajinomoto Co. Inc. Kyushu Plant, an API manufacturer in Saga, Japan, and found a significant failure to thoroughly review unexplained discrepancies. Deviation reports lacked scientific rationale, root cause analysis, and sufficient QA oversight, raising concerns about the quality and purity of their APIs.

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/ajinomoto-co-inc-kyushu-plant/a8db0df1-8adb-4372-90d2-b26fae43487f

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