Drug factory · FDA FEI 1000280888

Indena SpA

Via Don Giovanni Minzoni 6, Settala, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 26, 2021.

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

16 drug inspections on record since 2008: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
ColchicineMakes the active ingredient Scilex Pharmaceuticals Inc. 69557-222
ThiotepaMakes the active ingredient and tests it Amneal Pharmaceuticals LLC 70121-1630, 70121-1631, 70121-1687 +1

FDA inspection history

EndedResultProgramProblems noted
Nov 26, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 26, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
May 10, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
May 10, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 29, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 29, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 4, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 4, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 31, 2011Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 31, 2011Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 30, 2011No problems foundDrug Quality Assurance—
Mar 30, 2011No problems foundDrug Quality Assurance—
Oct 16, 2008No problems foundDrug Quality Assurance—
Oct 16, 2008No problems foundDrug Quality Assurance—
Oct 16, 2008No problems foundDrug Quality Assurance—
Oct 16, 2008No problems foundDrug Quality Assurance—

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