Drug factory · FDA FEI 3002807025
Fukuzyu Pharmaceutical Co., Ltd.
48, Hagihara, Toyama, Japan
Problems found, fixed voluntarily at FDA's last inspection, Nov 11, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 0 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pyrimethamine | Makes the active ingredient | Oakrum Pharma, LLC, Vyera Pharmaceuticals LLC | 72647-330, 69413-330 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 11, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 19, 2024 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jul 28, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.