Drug factory · FDA FEI 3013257850
Cenexi HSC
2 Rue Louis Pasteur, Herouville-Saint-Clair, France
Problems found, fixed voluntarily at FDA's last inspection, Mar 1, 2024.
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 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Methylene Blue Cation | Makes it | American Regent, Inc. | 0517-0371, 0517-0381 |
| Pegcetacoplan | Makes it, tests it, packages it and sterilizes it | Apellis Pharmaceuticals, Inc. | 73606-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 1, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 26, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.