Drug factory · FDA FEI 3002808164

Zach System S.a.

ZONE INDUSTRIELLE CROIX CADEAU, Avrille, France

France: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 12, 2021.

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 2009: 2 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
Metformin and PioglitazoneMakes the active ingredient Takeda Pharmaceuticals America, Inc. 64764-158
SebetralstatMakes the active ingredient KalVista Pharmaceuticals Ltd 82928-300

FDA inspection history

EndedResultProgramProblems noted
Feb 12, 2021Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 7, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 16, 2014No problems foundDrug Quality Assurance—
Dec 2, 2010No problems foundDrug Quality Assurance—
Jun 11, 2009Serious problems, FDA actionDrug Quality Assurance—

Registered with FDA for: api manufacture.