Drug factory · FDA FEI 1000588788
Guerbet Ireland Unlimited Company
Damastown Industrial Estate Mulhuddart, Dublin, Ireland
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.
2 drug inspections on record since 2016: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ioversol | Makes the active ingredient | Liebel-Flarsheim Company LLC | 0019-1323, 0019-1332, 0019-1333 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 16, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 3, 2016 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; pack.