Drug factory · FDA FEI 3014150588
BeOne Pharmaceutical (Suzhou) Co.,Ltd
Building 9, 218 Sangtian St., Suzhou Industrial Park, Suzhou Area Pilot Free Trade Zone, Suzhou, China
Problems found, fixed voluntarily at FDA's last inspection, Jun 16, 2023.
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 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tislelizumab | Tests it | BeOne Medicines USA, Inc. | 72579-121, 72579-125 |
| Zanubrutinib | Tests it | BeOne Medicines USA, Inc. | 72579-011, 72579-122 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis.