Drug factory · FDA FEI 3009975775
Fujimoto Chemicals Co., Ltd.
1-24, Rinkai-cho, Izumiotsu, Japan
Problems found, fixed voluntarily at FDA's last inspection, May 12, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2013: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fezolinetant | Makes the active ingredient | Astellas Pharma US, Inc. | 0469-2460, 0469-2660, 0469-2760 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 12, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 15, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.