Drug factory · FDA FEI 3003973514
Sumitomo Chemical Company, Limited
6-4-1, Kojimatanokuchi, Kurashiki, Japan
No problems found at FDA's last inspection, Nov 2, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2011: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mirabegron | Makes the active ingredient | Astellas Pharma US, Inc. | 0469-2601, 0469-2602, 0469-5020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 2, 2023 | No problems found | Drug Quality Assurance | — |
| Jul 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 25, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.