Drug factory · FDA FEI 3010606982
WuXi Biologics Co., Ltd.
108 Meiliang Road, Mashan, Binhu District, Wuxi, China
Problems found, fixed voluntarily at FDA's last inspection, Jul 3, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2019: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nipocalimab | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-800, 57894-801 |
| Pemivibart | Makes the active ingredient and tests it | Invivyd, Inc | 81960-031 |
| Vilobelimab | Makes it, makes the active ingredient and tests it | InflaRx GmbH | 83000-110 |
| Zanidatamab | Makes it and tests it | Jazz Pharmaceuticals, Inc. | 68727-950 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 3, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 2, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.