Drug factory · FDA FEI 3002806597
China Resources Saike Pharmaceutical Co., Ltd.
No.3, Jinghai 7th Street, Tongzhou Dist., Beijing, China
No problems found at FDA's last inspection, Jul 1, 2022.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amlodipine | Makes it | China Resources Saike Pharmaceutical Co., Ltd. | 43489-100, 43489-101, 43489-102 |
| Levetiracetam | Makes it | China Resources Saike Pharmaceutical Co., Ltd. | 43489-122, 43489-124 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 1, 2022 | No problems found | Drug Quality Assurance | — |
| Aug 3, 2018 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2016 | No problems found | Drug Quality Assurance | — |
| Jan 16, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 23, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.