Drug factory · FDA FEI 3005742674
Nelson Labs NV
Romeinsestraat 12, Leuven, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Apr 30, 2024.
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 2017: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lunsotogene Parvec | Tests it | Regeneron Pharmaceuticals, Inc. | 61755-062 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 30, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 22, 2017 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.