Drug factory · FDA FEI 3003877372
Doppel Farmaceutici S.r.l.
Via Volturno, 48, Quinto de' Stampi - Rozzano, Italy
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2023: 0 with no problems, 2 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. | 81806-200, 81806-213, 70710-2007 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.