# FDA 483 - Otsuka Pharmaceutical Co., Ltd. - July 07, 2025

Source: https://www.globalkeysolutions.net/records/483/otsuka-pharmaceutical-co-ltd/65d3e912-60d3-4e10-ae9a-58f2210264b1

> FDA 483 for Otsuka Pharmaceutical Co., Ltd. on July 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Otsuka Pharmaceutical Co., Ltd.
- Inspection Date: 2025-07-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Otsuka Pharmaceutical Co., Ltd. in Kanzaki-Gun, Saga, Japan, revealed significant deficiencies in their API manufacturing processes. The firm failed to ensure that test methods and specifications for a critical (b)(4) API reference standard were scientifically sound and appropriately validated. This included a lack of validation for the in-house reference standard and insufficient quality oversight during its manufacturing.

## Related Documents

- [483 - 2019-02-28](https://www.globalkeysolutions.net/records/483/otsuka-pharmaceutical-co-ltd/39f40888-2a2c-4828-8d2c-ad2de5a90622)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/otsuka-pharmaceutical-co-ltd/c050e25d-d3f2-41d0-a3e6-cd706dc4c417

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