Drug factory · FDA FEI 3002806757

CU Chemie Uetikon GmbH

Raiffeisenstr. 4, Lahr, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 2025.

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 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
EsketamineMakes the active ingredient and tests it Janssen Pharmaceuticals, Inc. 50458-028
Phenylbutyric AcidMakes the active ingredient Acer Therapeutics Inc. 72542-200, 72542-300, 72542-400 +3

FDA inspection history

EndedResultProgramProblems noted
Jan 30, 2025Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 12, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 20, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 21, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
May 16, 2013No problems foundDrug Quality Assurance—
Apr 1, 2010Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.