Drug factory · FDA FEI 1000171506

Bracco Imaging Spa

Via Per Ceriano Laghetto, Ceriano Laghetto, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Oct 28, 2022.

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

3 drug inspections on record since 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Gadolinium Cation (3+)Makes the active ingredient Bracco Diagnostics Inc. 0270-5164, 0270-5264
GadoteridolMakes the active ingredient Bracco Diagnostics Inc. 0270-1111
IopamidolMakes the active ingredient Bracco Diagnostics Inc. 0270-1314, 0270-1315, 0270-1316 +3

FDA inspection history

EndedResultProgramProblems noted
Oct 28, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 15, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
May 6, 2016No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.