Drug factory · FDA FEI 3002740213

Bracco Suisse SA

Route de la Galaise 31, Plan-les-Ouates, Switzerland

Switzerland: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 4, 2024.

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

5 drug inspections on record since 2012: 3 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
Distearoylphosphatidylcholine, Dl- and Sodium 1,2-Dipalmitoyl-Sn-Glycero-3-Phospho-(1'-Rac-Glycerol) and Sulfur HexafluorideMakes it and tests it Bracco Diagnostics Inc. 0270-7097, 0270-7099

FDA inspection history

EndedResultProgramProblems noted
Jul 4, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 27, 2018No problems foundDrug Quality Assurance—
Jul 26, 2016No problems foundDrug Quality Assurance—
Aug 8, 2014No problems foundDrug Quality Assurance—
Apr 27, 2012Serious problems, FDA actionDrug Quality Assurance—

Registered with FDA for: analysis; manufacture.