Drug factory · FDA FEI 3002807284
Ifts
3 rue Marcel Pagnol, Foulayronnes, France
Problems found, fixed voluntarily at FDA's last inspection, Jul 29, 2021.
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 2016: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Iodine | Tests it | Guerbet LLC | 67684-1901 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 29, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 18, 2016 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written laboratory mechanisms are not justified .
Registered with FDA for: analysis.