Drug factory · FDA FEI 3001451441
Lonza Biologics, Inc.
101 International Drive, Portsmouth, NH, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 6, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 1 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Efgartigimod Alfa | Makes the active ingredient | argenx US | 73475-3041 |
| Efgartigimod Alfa and Hyaluronidase (human Recombinant) | Makes the active ingredient | argenx US | 73475-1221 |
| Eftrenonacog Alfa | Makes the active ingredient and tests it | Bioverativ Therapeutics Inc. | 71104-911, 71104-922, 71104-933 +3 |
| Isatuximab | Makes the active ingredient and tests it | Sanofi-Aventis U.S. LLC | 0024-0654, 0024-0656 |
| Obiltoxaximab | Makes the active ingredient and tests it | Elusys Therapeutics, Inc. | 69604-204 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 6, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 21, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 21, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 30, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 21, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 3, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.