Drug factory · FDA FEI 3004797574
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe 1, Cortemaggiore, Italy
Problems found, fixed voluntarily at FDA's last inspection, Jun 17, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Deflazacort | Makes it, tests it and labels it | Doppel Farmaceutici S.r.l., Zydus Pharmaceuticals (USA) Inc. | 81806-174, 81806-175, 81806-176 +13 |
| Icosapent | Makes it, tests it, packages it and labels it | Zydus Pharmaceuticals (USA) Inc. | 70710-1592, 70710-1738 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.