Drug factory · FDA FEI 3004764499
Millmount Healthcare Limited
Block 7, City North Business Campus, Stamullen, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Dec 9, 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 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cytarabine and Daunorubicin | Packages it and labels it | Jazz Pharmaceuticals, Inc. | 68727-745 |
| Vestronidase Alfa | Packages it and labels it | Ultragenyx Pharmaceutical Inc. | 69794-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 9, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 22, 2015 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: label; manufacture; pack; relabel; repack.