Drug factory · FDA FEI 3001599766
Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd.
No. 302, Huzhuangtou, Sanhuangmiao, Zhenglu, Tianning, Changzhou, China
Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone and Niraparib | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-050, 57894-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 26, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 12, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.