# FDA 483 - Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. - March 07, 2025

Source: https://www.keypedia.com/records/483/hangzhou-minsheng-binjiang-pharmaceutical-co-ltd/2e694383-a505-4680-b521-85714911f8ef

> FDA 483 for Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. on March 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
- Inspection Date: 2025-03-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. in Hangzhou, China, revealed significant deficiencies in equipment cleaning, out-of-specification investigation procedures, and quality control unit adherence to GMP documentation. Inspectors found active pharmaceutical ingredient residue in "cleaned" equipment, inadequate OOS investigations, and discarded GMP documents in the QC lab. These observations indicate a lack of control over manufacturing processes and quality systems.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

Company: https://www.keypedia.com/companies/hangzhou-minsheng-binjiang-pharmaceutical-co-ltd/60558281-5fe9-47ef-a772-a976c821d6b2

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