Drug factory · FDA FEI 3001168779

Flamma S.p.A.

Via Bedeschi 22, Chignolo d'Isola, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 25, 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: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
RilzabrutinibMakes the active ingredient Genzyme Corporation 58468-0251

FDA inspection history

EndedResultProgramProblems noted
Mar 25, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 17, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 20, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 21, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 29, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.