Drug factory · FDA FEI 3003404148
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
Dongjin Road, Port Industry Area, Economic and Technological Development Zone, Lianyungang, China
Problems found, fixed voluntarily at FDA's last inspection, Aug 29, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2015: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupivacaine | Makes it | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3251, 57884-3252 |
| Dexmedetomidine | Makes it | Sandoz Inc. | 0781-3493, 0781-3494, 0781-3495 |
| Fondaparinux | Makes it, tests it, packages it, labels it and sterilizes it | Sandoz Inc. | 0781-3443, 0781-3454, 0781-3465 +1 |
| Gadolinium Cation (3+) | Makes it | Fresenius Kabi USA, LLC | 65219-088, 65219-287, 65219-289 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 29, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 24, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.