Drug factory · FDA FEI 3015528193
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate, Dundalk, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Nov 10, 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 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cerliponase Alfa | Packages it and labels it | BioMarin Pharmaceutical Inc. | 68135-811 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 27, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; pack; relabel; repack.