Drug factory · FDA FEI 3002807208
Hovione Farmaciencia, S.a.
Quinta Sao Pedro, Loures, Portugal
Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2009: 4 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ensifentrine | Makes the active ingredient and tests it | Merck Sharp & Dohme LLC | 83034-003 |
| Lefamulin | Tests it | Nabriva Therapeutics US, Inc. | 72000-110, 72000-120 |
| Minocycline | Makes the active ingredient | Journey Medical Corporation | 69489-201 |
| Paltusotine | Makes the active ingredient | Catalent Pharma Solutions, LLC | 11014-0737, 11014-0738 |
| Plazomicin | Makes the active ingredient and tests it | Achaogen, Inc., Cipla Therapeutics Inc., Cipla USA., Inc. | 71045-010, 80735-820, 69097-820 |
| Sonrotoclax | Makes it and tests it | BeOne Medicines USA, Inc. | 72579-015, 72579-017, 72579-020 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 24, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 10, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 12, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 3, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 26, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 5, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 29, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 27, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.