# FDA 483 - Bushu Pharmaceuticals Ltd. - December 02, 2022

Source: https://www.globalkeysolutions.net/records/483/bushu-pharmaceuticals-ltd/b6765841-7334-4c55-a03f-48209c769b8e

> FDA 483 for Bushu Pharmaceuticals Ltd. on December 02, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Bushu Pharmaceuticals Ltd.
- Inspection Date: 2022-12-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bushu Pharmaceuticals Ltd. in Kawagoe, Japan, revealed significant deficiencies across its operations. The firm failed to adequately document and follow quality control unit procedures for complaints, deviations, and laboratory investigations. Additionally, established laboratory test procedures and facility control systems were found to be deficient, leading to concerns about data integrity, contamination prevention, and proper material segregation.

## Related Documents

- [483 - 2022-12-02](https://www.globalkeysolutions.net/records/483/bushu-pharmaceuticals-ltd/47c2fcd8-6261-4cbd-a7fb-ee65aeee4c88)

## Related Officers

- [MRA MunizN](https://www.globalkeysolutions.net/people/mra-munizn/11f33537-1745-4bda-859c-24ac35a3fe45)

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

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