Drug factory · FDA FEI 3002807778
GE Healthcare AS avd Lindesnes
Lindesnesveien 208, Lindesnes, Norway
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2017: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Gadodiamide | Makes the active ingredient | GE Healthcare Inc. | 0407-0690 |
| Gadolinium Cation (3+) | Makes the active ingredient and tests it | GE Healthcare Inc. | 0407-1066, 0407-2943 |
| Iohexol | Makes the active ingredient | GE Healthcare Inc. | 0407-1401, 0407-1411, 0407-1412 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 22, 2017 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; pack.