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

Source: https://www.globalkeysolutions.net/records/483/shanghai-henlius-biologics-co-ltd/d6806e72-e2ac-48ef-93a4-336d3aff995b

> FDA 483 for Shanghai Henlius Biologics Co., Ltd. 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.
- Inspection Date: 2025-03-11
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Shanghai Henlius Biologics Co., Ltd. in Songjiang District, Shanghai, China, revealed inadequate quality unit oversight. Specifically, the firm's visual inspection process for drug product samples was found to be inadequate, and deficiencies were noted in the qualification and requalification studies of HEPA filters for the ABS filling line. These observations highlight concerns with the firm's quality control and environmental monitoring practices.

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## Related Officers

- [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)
- [Qiao Bobo, Ph.D. Division Director](https://www.globalkeysolutions.net/people/qiao-bobo-phd-division-director/6ed34b60-6ce6-4dcc-adf2-07eced1f04d9)

Company: https://www.globalkeysolutions.net/companies/shanghai-henlius-biologics-co-ltd/ca560713-8df4-4bed-a460-7157ef410918

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