Drug factory · FDA FEI 3009010397
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
No. 16 Xingguo Road, Xiuying District, Haikou City, China
Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bivalirudin | Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-034 |
| Eptifibatide | Makes it, makes the active ingredient, tests it, packages it, labels it and sterilizes it | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-040, 52958-402 |
| Octreotide | Makes it, makes the active ingredient, tests it, packages it and labels it | Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 52958-046 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 28, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 22, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; sterilize.