Drug factory · FDA FEI 3002806293

Acs Dobfar Spa

VIA TONALE 87, Albano Sant'Alessandro (BG), Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 23, 2022.

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

5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AmikacinMakes the active ingredient Insmed Incorporated 71558-590

FDA inspection history

EndedResultProgramProblems noted
Sep 23, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 14, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 17, 2016No problems foundDrug Quality Assurance—
Mar 28, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 5, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; pack.