# Daiichi Sankyo Co., Ltd. Hiratsuka Plant – FDA 483, Apr 21, 2026

Source: https://www.keypedia.com/records/483/daiichi-sankyo-co-ltd-hiratsuka-plant/f63590c1-c14a-4664-b4bb-7c1ebb10e92c

> FDA 483 for Daiichi Sankyo Co., Ltd. Hiratsuka Plant on April 21, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daiichi Sankyo Co., Ltd. Hiratsuka Plant
- Inspection Date: 2026-04-21
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Daiichi Sankyo Co., Ltd.'s Hiratsuka Plant revealed significant deficiencies in the manufacturing of sterile injectable drug products. Observations included failures in aseptic process controls, inadequate quality control unit procedures, and insufficient environmental monitoring. The inspection also cited issues with facility maintenance, visual inspection programs, smoke studies, and laboratory controls, indicating a broad range of non-compliance with good manufacturing practices.

## Related Officers

- [Chemist](https://www.keypedia.com/people/jeanne-fringer/c38f5762-9feb-4838-8624-6f213e06adbf)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/andrea-franco/96b35431-a713-48a5-9a47-e160cc650730)

Company: https://www.keypedia.com/companies/daiichi-sankyo-co-ltd-hiratsuka-plant/d9bb5238-4acc-4fc5-8638-db754e816be8

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4