Drug factory · FDA FEI 3006689263
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)
22 Jinqiao Road, Dapu Industrial Park, Economic and Technological Development Zone, Lianyungang, China
Problems found, fixed voluntarily at FDA's last inspection, Apr 15, 2026.
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: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 4-Hydroxycyclophosphamide | Makes it, makes the active ingredient, tests it and packages it | Fresenius Kabi USA, LLC | 65219-131, 65219-133, 65219-135 |
| Bupivacaine | Makes the active ingredient | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | 57884-3251, 57884-3252 |
| Gadolinium Cation (3+) | Makes the active ingredient | Fresenius Kabi USA, LLC | 65219-281 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 15, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 28, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 10, 2013 | No problems found | Drug Quality Assurance | — |
| Aug 20, 2013 | No problems found | Drug Quality Assurance | — |
| Aug 1, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction; sterilize.