Drug factory · FDA FEI 3008316144
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. FDF site
No.5 Dongjin Road, Economic and Technical Development Zone., Lianyungang, China
Serious problems, FDA action at FDA's last inspection, Apr 24, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
2 drug inspections on record since 2019: 0 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bortezomib | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0143-9098 |
| Fulvestrant | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0143-9022 |
| Micafungin | Makes it | Sagent Pharmaceuticals | 25021-190, 25021-191 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 24, 2026 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jun 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.