Drug factory · FDA FEI 3002807904
Pliva Hrvatska d.o.o.
Prilaz Baruna Filipovica 25, Zagreb, Croatia
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2012: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lovastatin | Makes it | International Laboratories, LLC | 54458-844, 54458-845, 54458-846 |
| Metronidazole | Makes it | Upsher-Smith Laboratories, Inc. | 0245-0860 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 27, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 31, 2018 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Mar 23, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 3, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 9, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; repack; sterilize.