Drug factory · FDA FEI 3003562118
Ercros SA
Paseo del Deleite S/N, Aranjuez, Spain
Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2018.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2011: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fosfomycin | Makes the active ingredient and tests it | Cipla USA., Inc., Meitheal Pharmaceuticals Inc. | 69097-579, 71288-035 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 22, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 15, 2011 | Serious problems, FDA action | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.