Drug factory · FDA FEI 3008481334
Hisun Pharmaceutical (Hangzhou) Co., Ltd.
No.1, Haizheng Road, Xukou Town, Fuyang District, Hangzhou, China
Problems found, fixed voluntarily at FDA's last inspection, Mar 26, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2012: 0 with no problems, 5 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dactinomycin | Makes it and makes the active ingredient | Hisun Pharmaceuticals USA Inc. | 42658-008 |
| Daptomycin | Makes it | Hisun Pharmaceuticals USA Inc. | 42658-011 |
| Daunorubicin | Makes it | Hisun Pharmaceuticals USA Inc. | 42658-019, 42658-021 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 20, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture; manufacture.