Drug factory · FDA FEI 3008699637
Almac Sciences Limited
Almac House, 20 Seagoe Industrial Estate, Craigavon, United Kingdom
No problems found at FDA's last inspection, May 8, 2025.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2012: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Flotufolastat F-18 | Makes the active ingredient | Blue Earth Diagnostics | 69932-002 |
| Ixazomib | Tests it | Takeda Pharmaceuticals America, Inc. | 63020-230, 63020-390, 63020-400 |
| Selexipag | Makes the active ingredient and tests it | Actelion Pharmaceuticals US, Inc. | 66215-602, 66215-604, 66215-606 +9 |
| Uridine | Makes the active ingredient and tests it | BTG International Inc. | 50633-220, 50633-330 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 8, 2025 | No problems found | Drug Quality Assurance | — |
| Sep 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 28, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 5, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 22, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.