Drug factory · FDA FEI 3002808100

Sicor Societa' Italiana Corticosteroidi s.r.l ABBREVIATA IN SICOR S.R.L.

Tenuta S. Alessandro, Santhia, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 15, 2022.

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: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BudesonideMakes the active ingredient Calliditas Therapeutics AB 81749-004

FDA inspection history

EndedResultProgramProblems noted
Apr 15, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 21, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 15, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 22, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 12, 2012Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 16, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.