# FDA 483 - Zhejiang Dingtai Pharmaceutical Co., Ltd - January 25, 2019

Source: https://www.globalkeysolutions.net/records/483/zhejiang-dingtai-pharmaceutical-co-ltd/a04d3fcf-f0ad-4915-b2b4-cffe0ad15da7

> FDA 483 for Zhejiang Dingtai Pharmaceutical Co., Ltd on January 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Dingtai Pharmaceutical Co., Ltd
- Inspection Date: 2019-01-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Dingtai Pharmaceutical Co., Ltd. in Tongxiang, China, revealed significant deficiencies across four observations. The firm failed to maintain adequate laboratory controls, including system suitability testing and electronic data review, and exhibited poor data integrity practices. Additionally, batch production and control records were incomplete, lacking documentation of critical manufacturing steps and proper record reconciliation, indicating a general lack of adherence to good manufacturing practices.

## Related Officers

- [Kara Dobbin](https://www.globalkeysolutions.net/people/kara-dobbin/0b35e025-4389-46df-abcb-30e70693f62b)

Company: https://www.globalkeysolutions.net/companies/zhejiang-dingtai-pharmaceutical-co-ltd/5ad59204-cae0-40c4-89df-50126877724c

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