Drug factory · FDA FEI 3002807618

Micro-Macinazione Sa

VIA CANTONALE 4, Monteggio, Switzerland

Switzerland: 1

Problems found, fixed voluntarily at FDA's last inspection, Nov 13, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2012: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BudesonideMills it Calliditas Therapeutics AB 81749-004
MacitentanTests it and mills it Actelion Pharmaceuticals US, Inc. 66215-501
OteseconazoleMills it Mycovia Pharmaceuticals, Inc. 74695-823
TeriflunomideMakes the active ingredient Genzyme Corporation 58468-0210, 58468-0211

FDA inspection history

EndedResultProgramProblems noted
Nov 13, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
May 31, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 30, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
May 30, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 30, 2012No problems foundDrug Quality Assurance—
Mar 30, 2012No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; particle size reduction.