Drug factory · FDA FEI 3004537783
InfoRLife SA
Casai, Campascio, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, May 3, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetaminophen | Makes it | WG Critical Care, LLC. | 44567-340 |
| Calcium Cation | Makes it | WG Critical Care, LLC. | 44567-620, 44567-621, 44567-622 +1 |
| Diltiazem | Makes it, tests it, packages it and labels it | WG Critical Care, LLC. | 44567-662, 44567-663 |
| Edaravone | Makes it | Sandoz Inc. | 0781-3527 |
| Levofloxacin | Makes it | WG Critical Care, LLC. | 44567-435, 44567-436, 44567-437 |
| Magnesium Cation | Makes it | WG Critical Care, LLC. | 44567-170, 44567-410, 44567-420 +4 |
| Metronidazole | Makes it | WG Critical Care, LLC. | 44567-750 |
| Midazolam | Makes it | WG Critical Care, LLC. | 44567-610, 44567-611 |
| Norepinephrine | Makes it | WG Critical Care, LLC. | 44567-640, 44567-641, 44567-642 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 3, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 10, 2019 | No problems found | Drug Quality Assurance | — |
| Feb 23, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 16, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 4, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 5, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.