Drug factory · FDA FEI 3014310427
Shanghai STA Pharmaceutical Product Co., Ltd.
31 Yiwei Road, Waigaoqiao Free Trade Zone, Shanghai, China
Problems found, fixed voluntarily at FDA's last inspection, Feb 28, 2025.
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 2024: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Vadadustat | Makes it and tests it | Akebia Therapeutics, Inc. | 59922-641, 59922-642, 59922-643 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 28, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.