Drug factory · FDA FEI 3002806965

Farmabios S.p.A.

Via Pavia 1, Gropello Cairoli, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 1, 2021.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DifluprednateMakes the active ingredient Cipla USA., Inc., Exelan Pharmaceuticals, Inc. 69097-341, 76282-708
FluticasoneMakes the active ingredient Morton Grove Pharmaceuticals, Inc. 60432-264
HalcinonideMakes the active ingredient Caraco Pharmaceutical Laboratories, Ltd. 10631-094

FDA inspection history

EndedResultProgramProblems noted
Oct 1, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 20, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 26, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 23, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 13, 2013No problems foundDrug Quality Assurance—
Sep 23, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.