Drug factory · FDA FEI 3003562118

Ercros SA

Paseo del Deleite S/N, Aranjuez, Spain

Spain: 1

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

DrugRoleForNDC
FosfomycinMakes the active ingredient and tests it Cipla USA., Inc., Meitheal Pharmaceuticals Inc. 69097-579, 71288-035

FDA inspection history

EndedResultProgramProblems noted
Jun 22, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 12, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 15, 2011Serious problems, FDA actionDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.