# FDA 483 - Zhejiang Guobang Pharmaceutical Co., Ltd - March 03, 2025

Source: https://www.keypedia.com/records/483/zhejiang-guobang-pharmaceutical-co-ltd/940729c8-9f67-4a2b-b16b-31436888e32a

> FDA 483 for Zhejiang Guobang Pharmaceutical Co., Ltd on March 03, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Guobang Pharmaceutical Co., Ltd
- Inspection Date: 2025-03-03
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Zhejiang Guobang Pharmaceutical Co., Ltd. revealed significant deficiencies in laboratory controls related to their water systems used in drug substance manufacturing. The firm lacked scientifically justified specifications and test procedures for (b)(4) water, failing to ensure its identity, quality, and purity. This included inadequate microbial monitoring, failure to detect potential biofilms, and insufficient speciation of microorganisms in their water system.

## Related Officers

- [Monica E. Murie](https://www.keypedia.com/people/monica-e-murie/2db840df-d69f-4def-9830-fd461bea5507)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

Company: https://www.keypedia.com/companies/zhejiang-guobang-pharmaceutical-co-ltd/26334d34-b5ce-4ef2-ab1d-455003edad45

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8