# FDA 483 - Livzon Group (Ningxia) Pharmaceutical Co., Ltd. - October 19, 2018

Source: https://www.globalkeysolutions.net/records/483/livzon-group-ningxia-pharmaceutical-co-ltd/ca2b5e84-c11a-4060-af74-e395a6c584ed

> FDA 483 for Livzon Group (Ningxia) Pharmaceutical Co., Ltd. on October 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Livzon Group (Ningxia) Pharmaceutical Co., Ltd.
- Inspection Date: 2018-10-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Livzon Group (Ningxia) Pharmaceutical Co., Ltd., an API and intermediate manufacturer, and found significant deficiencies across multiple areas. These included inadequate equipment cleaning, poor warehousing controls, facilities in disrepair, and insufficient labeling procedures. The inspection also revealed issues with stability studies, inventory records, environmental monitoring, OOS investigations, laboratory controls, batch record documentation, and shipping records.

## Related Documents

- [483 - 2019-12-06](https://www.globalkeysolutions.net/records/483/livzon-group-ningxia-pharmaceutical-co-ltd/9bfeb219-f90b-492a-9ffd-2097dfac7b48)

## Related Officers

- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/livzon-group-ningxia-pharmaceutical-co-ltd/78a1f9d4-41d0-440a-87bc-8c9521d0159a

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