Drug factory · FDA FEI 3011071488
Bushu Pharmaceuticals, Ltd.
950 Hiroki, Misatomachi, Kodama-gun, Japan
No problems found at FDA's last inspection, Nov 10, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2017: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Rufinamide | Makes it, tests it and packages it | Eisai Inc. | 62856-582, 62856-583 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 10, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 30, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 2, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.