# Bushu Pharmaceuticals Ltd. – FDA 483, Aug 3, 2026

Source: https://www.keypedia.com/records/483/bushu-pharmaceuticals-ltd/136ded1a-5d12-43bf-974f-40b279879896

> FDA 483 for Bushu Pharmaceuticals Ltd. on August 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bushu Pharmaceuticals Ltd.
- Inspection Date: 2026-08-03
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Bushu Pharmaceuticals Ltd. in Kawagoe, Japan, a drug manufacturer, revealed significant deficiencies in sample management and record-keeping. The firm failed to establish adequate written procedures for in-process controls and maintain complete laboratory records, leading to unaccounted excess samples and insufficient tracking of drug product units during testing. These issues indicate a lack of control over critical quality processes and data integrity.

## Related Documents

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## Related Officers

- [WenNing Chan](https://www.keypedia.com/people/wenning-chan/973bf578-405d-46cf-b09e-254d6db07c08)

Company: https://www.keypedia.com/companies/bushu-pharmaceuticals-ltd/f3ccab51-b6fa-4873-b2de-61ba32d7967e

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3