Drug factory · FDA FEI 3002807302
Sigma-Aldrich Ireland Limited
Vale Road, Arklow, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Aug 26, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Alcohol | Makes the active ingredient, tests it, packages it and labels it | Belcher Pharmaceuticals,LLC | 62250-105 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 26, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 12, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 19, 2016 | No problems found | Drug Quality Assurance | — |
| Nov 2, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 12, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.