Drug factory · FDA FEI 3008190361
Cyndea Pharma SL
Avenida Agreda (Pol Ind Emiliano Revilla Sanz) 31, Olvega OLVEGA, Soria, Spain
Problems found, fixed voluntarily at FDA's last inspection, Mar 10, 2022.
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 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Drospirenone and Ethinyl Estradiol | Makes it and tests it | Camber Pharmaceuticals Inc. | 31722-934, 31722-945 |
| Ethinyl Estradiol and Levonorgestrel | Makes it | Camber Pharmaceuticals Inc. | 31722-944 |
| Ethinyl Estradiol and Norethindrone | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-849 |
| Nintedanib | Makes it and tests it | Glenmark Pharmaceuticals Inc., USA | 68462-802, 68462-803 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 10, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 3, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.