# FDA 483 - Otsuka Pharmaceutical Co., Ltd. - October 22, 2019

Source: https://www.keypedia.com/records/483/otsuka-pharmaceutical-co-ltd/d3b34d94-f15f-409d-b27b-8a21017a34f0

> FDA 483 for Otsuka Pharmaceutical Co., Ltd. on October 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Otsuka Pharmaceutical Co., Ltd.
- Inspection Date: 2019-10-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Otsuka Pharmaceutical Co., Ltd. in Naka-Gun, Tokushima, Japan, was inspected and cited for significant deficiencies across its quality system, particularly concerning foreign particle contamination in drug products. The inspection revealed a systemic failure to thoroughly investigate discrepancies, identify root causes for contamination and customer complaints, and maintain adequate control over equipment, documentation, and computer systems. These issues indicate a severe lack of quality oversight impacting the safety, purity, and efficacy of drug products.

## Related Documents

- [483 - 2025-06-17](https://www.keypedia.com/records/483/otsuka-pharmaceutical-co-ltd/500e2ebb-23c6-432a-a86f-6865269ae086)

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

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

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