# FDA 483 - Astellas Pharma Inc. - July 17, 2026

Source: https://www.keypedia.com/records/483/astellas-pharma-inc/16e7b253-30b6-4634-ad49-069a5cf4a53f

> FDA 483 for Astellas Pharma Inc. on July 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Astellas Pharma Inc.
- Inspection Date: 2026-07-17
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Astellas Pharma Inc. in Yaizu-shi, Shizuoka, Japan, a drug product manufacturer, received a Form 483 with six observations highlighting significant deficiencies. The inspection revealed a lack of adequate controls in aseptic processing, environmental monitoring, visual inspection, equipment maintenance, facility control, and quality oversight. These issues collectively indicate a systemic breakdown in maintaining a controlled manufacturing environment and ensuring product quality and patient safety for sterile drug products.

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## Related Officers

- [Doan N. Singh](https://www.keypedia.com/people/doan-n-singh/e52cfbca-5710-4765-8c5e-d534946b648d)
- [issuing_officer](https://www.keypedia.com/people/charles-y-kuo/36d44416-c980-4b33-b62e-ea0761a46a46)

Company: https://www.keypedia.com/companies/astellas-pharma-inc/b0bdaca5-537e-4e43-9609-7ae4702f2f86

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