Drug factory · FDA FEI 3009725845
Lonza Biologics Tuas Pte. Ltd.
35 Tuas South Avenue 6, Singapore, Singapore
Problems found, fixed voluntarily at FDA's last inspection, Jun 27, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2012: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Trastuzumab Emtansine | Tests it | Genentech, Inc. | 50242-087, 50242-088 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 3, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.