Drug factory · FDA FEI 3002837900
Pliva Hrvatska d.o.o.
Prudnicka Cesta 54, Prigorje Brdovecko, Croatia
Problems found, fixed voluntarily at FDA's last inspection, Jan 21, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Armodafinil | Makes the active ingredient | Sandoz Inc., Teva Pharmaceuticals USA, Inc. | 0781-8029, 0781-8037, 0781-8045 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 21, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 10, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 17, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 17, 2015 | No problems found | Drug Quality Assurance | — |
| Aug 9, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.