Drug factory · FDA FEI 3003725792

PharmaZell GmbH

Rosenheimer Strasse 43, Raubling, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Jun 30, 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
AcetylcysteineMakes the active ingredient Glenmark Pharmaceuticals Inc., USA 68462-946
MesalamineMakes the active ingredient Takeda Pharmaceuticals America, Inc. 54092-100, 54092-189, 54092-191 +1

FDA inspection history

EndedResultProgramProblems noted
Jun 30, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 22, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 12, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 8, 2011No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture.