Drug factory · FDA FEI 3010319651
Jazz Pharmaceuticals Ireland Limited
Monksland, Athlone, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Feb 24, 2022.
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 2016: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 4-Hydroxybutanoic Acid | Makes it, tests it and packages it | Hikma Pharmaceuticals USA Inc., Jazz Pharmaceuticals, Inc. | 0054-9628, 68727-100 |
| Cytarabine and Daunorubicin | Makes it and tests it | Jazz Pharmaceuticals, Inc. | 68727-745 |
| Oxybate | Makes it, tests it and packages it | Jazz Pharmaceuticals, Inc. | 68727-150 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 25, 2018 | No problems found | Drug Quality Assurance | — |
| Jun 3, 2016 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.