Drug factory · FDA FEI 3007373503
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
38 Huanghe Road, Economic and Technological Development Zone, , Lianyungang, China
Serious problems, FDA action at FDA's last inspection, Jan 16, 2024.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
5 drug inspections on record since 2012: 2 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carmustine | Makes it, tests it, packages it, labels it and sterilizes it | Sandoz Inc. | 0781-3474 |
| Gadolinium Cation (3+) | Makes it | Fresenius Kabi USA, LLC | 65219-080, 65219-082, 65219-084 +2 |
| Oxaliplatin | Makes it | Sagent Pharmaceuticals | 25021-233 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 16, 2024 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 2, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 13, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 26, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.