Drug factory · FDA FEI 3002807213

IOI Oleo GmbH

Arthur-Imhausen-Str. 92, Witten, Germany

Germany: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 25, 2024.

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 2009: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
TriheptanoinMakes the active ingredient Ultragenyx Pharmaceutical Inc. 69794-050

FDA inspection history

EndedResultProgramProblems noted
Jul 25, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 17, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 27, 2015No problems foundDrug Quality Assurance—
May 7, 2009Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.