Drug factory · FDA FEI 3008219043
Almac Sciences (Ireland) Limited
IDA Business and Technology Park, Garrycastle, Athlone, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Jan 29, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2010: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Brigatinib | Tests it | Takeda Pharmaceuticals America, Inc. | 63020-090, 63020-113, 63020-180 +1 |
| Cytarabine and Daunorubicin | Tests it | Jazz Pharmaceuticals, Inc. | 68727-745 |
| Flotufolastat F-18 | Tests it | Blue Earth Diagnostics | 69932-002 |
| Maribavir | Tests it | Takeda Pharmaceuticals America, Inc. | 64764-800 |
| Ponatinib | Tests it | Takeda Pharmaceuticals America, Inc. | 63020-533, 63020-534, 63020-535 |
| Solriamfetol | Tests it | Axsome Therapeutics, Inc. | 81968-350, 81968-351 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 29, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 2, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 15, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.