Drug factory · FDA FEI 3006803926

bene pharmaChem GmbH & Co. KG

Bayerwaldstr. 7-9, Geretsried, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 8, 2018.

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 2008: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Pentosan PolysulfateMakes the active ingredient Janssen Pharmaceuticals, Inc. 50458-098

FDA inspection history

EndedResultProgramProblems noted
Nov 8, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
May 21, 2014No problems foundDrug Quality Assurance—
Jul 8, 2011Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 23, 2008Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.