Drug factory · FDA FEI 3003688035

Rolabo Outsourcing S.L.

Poligono Industrial Malpica, Calle J, Parcelas 3-4, Zaragoza, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 21, 2023.

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 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Canagliflozin and MetforminMakes the active ingredient Janssen Pharmaceuticals, Inc. 50458-940, 50458-941, 50458-942 +1

FDA inspection history

EndedResultProgramProblems noted
Dec 21, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 29, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 7, 2018No problems foundDrug Quality Assurance—
Jan 21, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 6, 2014No problems foundDrug Quality Assurance—
Jul 28, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.