Drug factory · FDA FEI 3002808180
Skyepharma Production Sas
ZONE INDUSTRIELLE CHESNES OUEST 55 RUE DU MONTMURIER, St. Quentin Fallavier, France
Problems found, fixed voluntarily at FDA's last inspection, Oct 27, 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 2010: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bismuth Cation and Metronidazole and Tetracycline | Makes it and tests it | H2-Pharma LLC | 61269-381, 61269-386 |
| Bisoprolol | Makes it | Orit Laboratories LLC | 15955-373, 15955-374 |
| Sotalol | Makes it, tests it, packages it and labels it | Legacy Pharma USA, Inc. | 83107-005, 83107-006, 83107-007 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 19, 2015 | No problems found | Drug Quality Assurance | — |
| May 31, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 2, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; relabel.