Drug factory · FDA FEI 3007065180
Kowa Company, Ltd.
2-18-57, Hatooka, Kita-ku, Nagoya, Japan
No problems found at FDA's last inspection, Sep 1, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2011: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pitavastatin | Makes it | Kowa Pharmaceuticals America, Inc. | 66869-104, 66869-204, 66869-404 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 1, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 9, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.