# FDA 483 - Yabao Pharmaceutical Co., Ltd. Beijing - April 20, 2022

Source: https://www.globalkeysolutions.net/records/483/yabao-pharmaceutical-co-ltd-beijing/7c6b27ac-6f09-4171-9b90-14978162dd6d

> FDA 483 for Yabao Pharmaceutical Co., Ltd. Beijing on April 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yabao Pharmaceutical Co., Ltd. Beijing
- Inspection Date: 2022-04-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Yabao Pharmaceutical Co., Ltd. in Beijing, P. R. China, revealed significant deficiencies in equipment qualification and quality control unit procedures. The firm failed to adhere to its own written procedures for equipment calibration and performance qualification. Additionally, issues were noted in stability studies, impurity reporting, and the thoroughness of investigations into out-of-trend and abnormal data.

## Related Officers

- [Laurimer Kuulan-Torres](https://www.globalkeysolutions.net/people/laurimer-kuulan-torres/c9c7d245-50a9-427b-962f-a50f00d7ada7)
- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/yabao-pharmaceutical-co-ltd-beijing/0abb3f06-8186-4497-83ba-1cd93ffce2a6

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