Drug factory · FDA FEI 3003744129
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
333 Jiangnan Road, Hengdian, Dongyang, China
No problems found at FDA's last inspection, Jul 28, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amantadine | Makes it | Zhejiang Jutai Pharmaceutical Co., Ltd. | 71765-009 |
| Metoprolol | Makes it | Oryza Pharmaceuticals Inc., Zhejiang Jutai Pharmaceutical Co., Ltd. | 72516-025, 72516-026, 72516-027 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 28, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 1, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture; manufacture.