Drug factory · FDA FEI 3008058822
Hovione Limited
Loughbeg, Ringaskiddy, Ireland
No problems found at FDA's last inspection, Jan 20, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2012: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lefamulin | Makes the active ingredient | Nabriva Therapeutics US, Inc. | 72000-110, 72000-120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 20, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 22, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 25, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 16, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.