Zach System S.a.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- France
- Registered address
- ZONE INDUSTRIELLE CROIX CADEAU, AVRILLE, 49240, France (FRA)
- Operations here
- api manufacture
- FDA identifiers
- FEI 3002808164 · DUNS 552044943
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-02-12
- VAIDrug Quality Assurance2017-12-07
- NAIDrug Quality Assurance2014-10-16
- NAIDrug Quality Assurance2010-12-02
- OAIDrug Quality Assurance2009-06-11
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- pioglitazone and metformin hydrochlorideTakeda Pharmaceuticals America, Inc.
- sebetralstatKalVista Pharmaceuticals Ltd
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.