Drug factory · FDA FEI 3008293991

Haupt Pharma Amareg GmbH

Donaustaufer Str. 378, Regensburg, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 26, 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 2013: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
MiltefosineMakes it Eton Pharmaceuticals, Inc., Profounda, Inc. 71863-135, 69051-300
TriheptanoinMakes it Ultragenyx Pharmaceutical Inc. 69794-050

FDA inspection history

EndedResultProgramProblems noted
Jul 26, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 7, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 10, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 26, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 22, 2013No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.