# FDA 483 - Shanghai Henlius Biologics Co., Ltd. - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/shanghai-henlius-biologics-co-ltd/92d1e7ea-c45d-46c4-b3d6-157a409f196e

> FDA 483 for Shanghai Henlius Biologics Co., Ltd. on January 24, 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: 2025-01-24
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)

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## Related Officers

- [Gunther H. Boekhoudt, Ph.D., Senior Biologist](https://www.globalkeysolutions.net/people/gunther-h-boekhoudt-phd-senior-biologist/55e47215-b3d6-4540-8126-50098cf5f1e0)
- [Zhong Li, Ph.D., Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/zhong-li-phd-senior-regulatory-specialist/8239f257-d22a-47ff-af8a-248ff122d717)
- [Ralph M. Bernstein, Ph.D., Biologist](https://www.globalkeysolutions.net/people/ralph-m-bernstein-phd-biologist/869a9b3e-d207-4126-9349-52a4c79f0da4)

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
