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GEXFIX SA — FDA Facility Profile

FEI 3005157180

GEXFIX SA is an FDA-registered facility (FEI 3005157180) located in Le Grand-Saconnex Geneve, CH. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Nov 21, 2024: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Jan 16, 2013
Warning letters
1 listed by FDA for this FEI, latest May 15, 2013

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Nov 21, 2024Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Design validation - user needs and intended uses (21 CFR 820.30(g))
Lack of or inadequate process validation (21 CFR 820.75(a))
Sep 4, 2014No Action Indicated (NAI)No citations listed
Jan 16, 2013Official Action Indicated (OAI)No citations listed

Facility details

Company
Gexfix SA
Location
Le Grand-Saconnex Geneve (CH)
Source
device

Compliance actions

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.