Drug factory · FDA FEI 3002807366

Justesa Imagen, S.A.U.

Avenida de San Pablo 27, Coslada, Spain

Spain: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 10, 2022.

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

4 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Diatrizoic AcidMakes the active ingredient, tests it, packages it and labels it Bracco Diagnostics Inc., Liebel-Flarsheim Company LLC 0270-0149, 0270-0445, 0270-1410 +1
Iothalamic AcidMakes the active ingredient Liebel-Flarsheim Company LLC 0019-0862

FDA inspection history

EndedResultProgramProblems noted
Mar 10, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 28, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 19, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 14, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture.