# FDA 483 - Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 - March 11, 2025

Source: https://www.globalkeysolutions.net/records/483/shanghai-henlius-biologics-co-ltd-songjiang-site-2/01291a1e-07e1-4780-9fb4-911b8d032766

> FDA 483 for Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2 on March 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2
- Inspection Date: 2025-03-11
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspected Shanghai Henlius Biologics Co., Ltd. Songjiang Site 2, a drug product manufacturer, and identified significant deficiencies. The inspection revealed inadequate process controls for sterility and product quality, inconsistent aseptic filling operations, and a lack of proper procedures to prevent microbiological contamination. Additionally, the firm's Quality Unit oversight was found to be insufficient, indicating a high risk to drug product quality and patient safety.

## Related Officers

- [Qiao Bobo, Ph.D. Division Director](https://www.globalkeysolutions.net/people/qiao-bobo-phd-division-director/6ed34b60-6ce6-4dcc-adf2-07eced1f04d9)
- [Liqun Zhao, Ph.D., Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/liqun-zhao-phd-pharmaceutical-scientist/0e11b4f1-7ccb-4636-be00-1be7f973d977)
- [Bo Chi, Ph.D., Microbiologist](https://www.globalkeysolutions.net/people/bo-chi-phd-microbiologist/69ddbe08-9e55-44fa-8cc3-96b19c9b21fd)

Company: https://www.globalkeysolutions.net/companies/shanghai-henlius-biologics-co-ltd-songjiang-site-2/33855203-3d77-4063-9838-38c20d7126b2

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd