# FDA 483 - Jiangxi Bioman Pharma Limited - July 30, 2022

Source: https://www.globalkeysolutions.net/records/483/jiangxi-bioman-pharma-limited/a59e52f2-d358-48fb-be54-befb073605bd

> FDA 483 for Jiangxi Bioman Pharma Limited on July 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangxi Bioman Pharma Limited
- Inspection Date: 2022-07-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Jiangxi Bioman Pharma Limited, an intermediate manufacturer in Shangrao, China, revealed significant deficiencies in their quality system. The firm failed to adequately follow quality unit procedures, including the proper classification and investigation of critical deviations. Additionally, the inspection found a lack of a scientifically sound cleaning validation program, raising concerns about potential cross-contamination.

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/jiangxi-bioman-pharma-limited/6664c08d-59bb-4070-bc38-adb686ba42f2

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