# FDA 483 - Ningbo Shuangcheng Pharmaceutical Co., Ltd - November 03, 2023

Source: https://www.globalkeysolutions.net/records/483/ningbo-shuangcheng-pharmaceutical-co-ltd/6a2430c3-8a22-423a-a30a-23c6e43afc7d

> FDA 483 for Ningbo Shuangcheng Pharmaceutical Co., Ltd on November 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ningbo Shuangcheng Pharmaceutical Co., Ltd
- Inspection Date: 2023-11-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Ningbo Shuangcheng Pharmaceutical Co., Ltd. in Ningbo, China, revealed two significant observations. The firm's quality control unit was found to lack proper responsibility for approving procedures and specifications, particularly concerning change control for document revisions. Additionally, equipment and utensils were not cleaned at appropriate intervals, leading to visible residue on primary packaging equipment.

## Related Officers

- [GDUFA Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kevin-p-regan/b870e1f2-017c-44ab-bc99-1ca99b474a04)

Company: https://www.globalkeysolutions.net/companies/ningbo-shuangcheng-pharmaceutical-co-ltd/942c1651-ee36-4163-9687-ca694ddc24d2

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