Drug factory · FDA FEI 3008409127

S.m. Farmaceutici SRL

Via Zona Industriale SNC, Tito, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 27, 2026.

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 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Acetate IonMakes it Milla Pharmaceuticals Inc. 71357-002, 71357-007, 71357-008 +1
IopamidolMakes it and tests it Bracco Diagnostics Inc. 0270-1314, 0270-1315, 0270-1316 +1
TromethamineMakes it Milla Pharmaceuticals Inc. 71357-001

FDA inspection history

EndedResultProgramProblems noted
Mar 27, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 22, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 28, 2016No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; manufacture.