Drug factory · FDA FEI 3002806531
Charles River Laboratories Ireland Limited
Carrentrila, Ballina, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Mar 31, 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 2008: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amikacin | Tests it | Insmed Incorporated | 71558-590 |
| Cytarabine and Daunorubicin | Tests it | Jazz Pharmaceuticals, Inc. | 68727-745 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 31, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 28, 2014 | No problems found | Drug Quality Assurance | — |
| May 20, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 11, 2008 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.