Drug plant · FDA FEI 1000238384
Simafex
16, avenue des Fours à Chaux, Marans, France
Problems found, fixed voluntarily at FDA's last inspection, Jan 31, 2025.
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: 1 with no problems, 4 with minor problems, 0 with serious problems.
What it does, for whom
- Gadolinium Cation (3+): makes the active ingredient for Guerbet LLC (NDC 67684-2000, 67684-2001, 67684-3001)
- Iodine: makes the active ingredient for Guerbet LLC (NDC 67684-1901)
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 31, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 25, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 27, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 15, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.