Drug factory · FDA FEI 3014405699
Zhejiang Poly Pharm. Co., Ltd
No. 78, Xinzhou Road, Economic Development Zone, Linping District, Hangzhou, China
Problems found, fixed voluntarily at FDA's last inspection, Nov 8, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amiodarone | Makes it | Hainan Poly Pharm. Co., Ltd., Slate Run Pharmaceuticals, LLC., Zhejiang Poly Pharm. Co., Ltd. | 14335-430, 14335-431, 14335-432 +4 |
| Azithromycin | Makes it and tests it | AiPing Pharmaceutical, Inc., Slate Run Pharmaceuticals, LLC., Zhejiang Poly Pharm. Co., Ltd. | 11788-128, 11788-129, 70436-220 +7 |
| Brivaracetam | Makes it, tests it, packages it and labels it | Zhejiang Poly Pharm. Co., Ltd. | 72673-031 |
| Fluconazole | Makes it, tests it and packages it | Slate Run Pharmaceuticals, LLC., Zhejiang Poly Pharm. Co., Ltd. | 70436-227, 72673-091 |
| Oseltamivir Acid | Makes it, tests it, packages it and labels it | Slate Run Pharmaceuticals, LLC., Zhejiang Poly Pharm. Co., Ltd. | 70436-225, 72673-101, 72673-102 +1 |
| Varenicline | Makes it | Rhodes Pharmaceuticals L.P. | 42858-562, 42858-563, 42858-564 |
| Voriconazole | Makes it, tests it, packages it and labels it | Slate Run Pharmaceuticals, LLC., Zhejiang Poly Pharm. Co., Ltd. | 70436-230, 72673-111 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 8, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.