Drug factory · FDA FEI 3002806667

CHEMI SpA

VIA VADISI 5, Patrica, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.

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: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
GivinostatMakes the active ingredient and tests it Italfarmaco S.p.A 11797-110

FDA inspection history

EndedResultProgramProblems noted
Jan 26, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 20, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 12, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 12, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 28, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 24, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.