# FDA 483 - Otsuka Pharmaceutical Co., Ltd. - June 17, 2025

Source: https://www.keypedia.com/records/483/otsuka-pharmaceutical-co-ltd/500e2ebb-23c6-432a-a86f-6865269ae086

> FDA 483 for Otsuka Pharmaceutical Co., Ltd. on June 17, 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: 2025-06-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Otsuka Pharmaceutical Co., Ltd. in Naka-Gun, Tokushima, Japan, a sterile drug product manufacturer, revealed significant deficiencies. The firm failed to establish adequate written procedures for production and process controls, particularly concerning aseptic processing validation and environmental monitoring. Additionally, laboratory controls for growth promotion testing were found to be deficient.

## Related Documents

- [483 - 2019-10-22](https://www.keypedia.com/records/483/otsuka-pharmaceutical-co-ltd/d3b34d94-f15f-409d-b27b-8a21017a34f0)

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/otsuka-pharmaceutical-co-ltd/4106c23b-a243-4485-8ab6-a3dd8a7258ad

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8