Drug factory · FDA FEI 3002807063

Guerbet

ZONE INDUSTRIELLE DE KERPONT 705 RUE DENIS PAPIN, Lanester, France

France: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 26, 2024.

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

2 drug inspections on record since 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
GadopiclenolMakes the active ingredient and tests it Bracco Diagnostics Inc., Guerbet LLC 0270-7015, 0270-7020, 0270-7025 +11

FDA inspection history

EndedResultProgramProblems noted
Apr 26, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 21, 2021Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.