Drug factory · FDA FEI 3002807440

Olon SpA

Via Milano 186, Garbagnate Milanese, Italy

Italy: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 13, 2023.

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 2014: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DicyclomineMakes the active ingredient Hikma Pharmaceuticals USA Inc., Slate Run Pharmaceuticals, LLC. 0054-0883, 0054-0885, 70436-147

FDA inspection history

EndedResultProgramProblems noted
Jul 13, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 9, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 23, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 28, 2014No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.