Drug factory · FDA FEI 3016529861
Shanghai Henlius Biopharmaceutical Co., Ltd.
Whole Building, Building 1 (Building D), No.1289 Yishan Road, Xuhui District, Shanghai, China
Problems found, fixed voluntarily at FDA's last inspection, Aug 18, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Trastuzumab | Tests it | Accord BioPharma Inc. | 69448-015, 69448-016, 69448-035 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.