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TEOXANE S.A. — FDA Facility Profile

FEI 3005975625

TEOXANE S.A. is an FDA-registered facility (FEI 3005975625) located in Geneva Geneve, CH. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jun 29, 2017: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Nov 16, 2012
Warning letters
1 listed by FDA for this FEI, latest Apr 19, 2013
Import refusals
10 or more

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
Jun 29, 2017No Action Indicated (NAI)No citations listed
Nov 16, 2012Official Action Indicated (OAI)Sponsor began study before IRB/FDA approval (21 CFR 812.42)
Sponsor progress reports for significant risk study (21 CFR 812.150(b)(5))
30-day sponsor notification to FDA (21 CFR 812.150(b)(7))

Facility details

Company
Teoxane S.A.
Location
Geneva Geneve (CH)
Source
device

Compliance actions

Import refusals

FDA data resources

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