Drug factory · FDA FEI 3005460102
Sinopep-Allsino Biopharmaceutical Co., Ltd.
No.28, Linpu Road, Economic & Technological Development Zone, , Lianyungang, China
Problems found, fixed voluntarily at FDA's last inspection, Sep 20, 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 2014: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oseltamivir Acid | Makes the active ingredient | Slate Run Pharmaceuticals, LLC., Zhejiang Poly Pharm. Co., Ltd. | 70436-225, 72673-101, 72673-102 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 20, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 18, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.