# FDA 483 - Shanghai Henlius Biopharmaceuticals Co., Ltd. - May 20, 2026

Source: https://www.keypedia.com/records/483/shanghai-henlius-biopharmaceuticals-co-ltd/63f556fa-efa4-430b-9800-1c8de5e4400c

> FDA 483 for Shanghai Henlius Biopharmaceuticals Co., Ltd. on May 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Henlius Biopharmaceuticals Co., Ltd.
- Inspection Date: 2026-05-20
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: The FDA inspection of Shanghai Henlius Biopharmaceutical Co., Ltd. revealed significant deficiencies in manufacturing process control, particularly concerning visible particulates in drug product batches. The firm also demonstrated inadequate investigation practices, retrospective changes to acceptance criteria without proper control, and failures in cleaning validation. Additionally, issues were noted in quality control laboratory procedures, electronic data integrity, equipment control in clean areas, and contamination prevention practices.

## Related Officers

- [Jie He](https://www.keypedia.com/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)
- [Xiaoshi Wang](https://www.keypedia.com/people/xiaoshi-wang/8249ff14-dec6-4ffd-9893-bdf8ba6af7ce)
- [Jiangsong Jiang](https://www.keypedia.com/people/jiangsong-jiang/055e81c4-48a9-423d-b90f-ea0d08df79e1)

Company: https://www.keypedia.com/companies/shanghai-henlius-biopharmaceuticals-co-ltd/27f2ead3-2366-4479-aa2e-d9895581080b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4