# FDA 483 - Ningxia Qiyuan Pharmaceutical Co., Ltd. - June 25, 2019

Source: https://www.globalkeysolutions.net/records/483/ningxia-qiyuan-pharmaceutical-co-ltd/f94bea60-ccfe-4962-946b-dd09d24728ae

> FDA 483 for Ningxia Qiyuan Pharmaceutical Co., Ltd. on June 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ningxia Qiyuan Pharmaceutical Co., Ltd.
- Inspection Date: 2019-06-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ningxia Qiyuan Pharmaceutical Co., Ltd., an API manufacturer in Yinchuan, China, was cited for six observations during a June 2019 FDA inspection. Key issues included repeat observations of non-contemporaneous record-keeping, inadequate quality unit responsibilities, insufficient contamination precautions, and poorly detailed cleaning and laboratory procedures. Additionally, the facility's buildings were not properly maintained, with water leaks observed in warehouses.

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## Related Officers

- [Marijo B. Kambere](https://www.globalkeysolutions.net/people/marijo-b-kambere/54e010f0-0d56-4b20-b5e2-112e372de58b)

Company: https://www.globalkeysolutions.net/companies/ningxia-qiyuan-pharmaceutical-co-ltd/c3f60fce-9615-4bb0-96fb-7df0b3242164

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