Drug factory · FDA FEI 3002894596
Siegfried El Masnou, S.A.
Calle Camil Fabra 58, El Masnou, Spain
Problems found, fixed voluntarily at FDA's last inspection, Feb 1, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Finafloxacin | Makes it | Fonseca Biosciences, LLC | 83709-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 1, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 3, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 5, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 9, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.