Drug factory · FDA FEI 3015655844
WuXi Biologics Biosafety Testing (Suzhou) Co., Ltd.
1336 Wuzhong Avenue, Xinzhiyuan Building B, Wuzhong District, Suzhou, China
Problems found, fixed voluntarily at FDA's last inspection, Feb 2, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Denosumab | Tests it | Organon LLC | 78206-193, 78206-195 |
| Efbemalenograstim Alfa | Tests it | Acrotech Biopharma Inc | 72893-016 |
| Nipocalimab | Tests it | Janssen Biotech, Inc. | 57894-800, 57894-801 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 2, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.