# FDA 483 - Livzon Group (Ningxia) Pharmaceutical Co., Ltd. - December 06, 2019

Source: https://www.globalkeysolutions.net/records/483/livzon-group-ningxia-pharmaceutical-co-ltd/9bfeb219-f90b-492a-9ffd-2097dfac7b48

> FDA 483 for Livzon Group (Ningxia) Pharmaceutical Co., Ltd. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Livzon Group (Ningxia) Pharmaceutical Co., Ltd.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lizvon Group (Ningxia) Pharmaceutical Co., an intermediate and API manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures in maintaining manufacturing equipment, specifically rusted tanks, and a lack of thorough investigation into out-of-specification results for multiple batches. These findings indicate issues with equipment integrity and quality control processes.

## Related Documents

- [483 - 2018-10-19](https://www.globalkeysolutions.net/records/483/livzon-group-ningxia-pharmaceutical-co-ltd/ca2b5e84-c11a-4060-af74-e395a6c584ed)

## Related Officers

- [Vincent Thomas](https://www.globalkeysolutions.net/people/vincent-thomas/0925480c-5d8c-411f-86ee-5e4b924f8c12)
- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

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