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

Source: https://www.keypedia.com/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.

---

## 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)
- Summary: Shanghai Henlius Biologics Co., Ltd. received a Form 483 for significant deficiencies in its drug substance manufacturing operations. Key issues include a dysfunctional quality unit, inadequate process controls, poorly maintained facilities and equipment, ineffective cleaning validation, and deficient laboratory controls for in-house media. These observations indicate a systemic lack of control over critical aspects of drug substance production and quality assurance.

## Related Documents

- [483 - 2023-08-01](https://www.keypedia.com/records/483/shanghai-henlius-biologics-co-ltd/80493937-1845-4891-b9a3-0375deb27cdd)
- [483 - 2025-03-11](https://www.keypedia.com/records/483/shanghai-henlius-biologics-co-ltd/d6806e72-e2ac-48ef-93a4-336d3aff995b)
- [EIR - 2025-03-11](https://www.keypedia.com/records/eir/shanghai-henlius-biologics-co-ltd/76c84f59-e928-48b4-adac-9158cb514123)

## Related Officers

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

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

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