FLECHARD S.A.S. — FDA Facility Profile

FEI 3004326340

FLECHARD S.A.S. is an FDA-inspected facility (FEI 3004326340) located in Zi La Chapelle D' Andaine, FR. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jan 17, 2020: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Feb 20, 2015
Warning letters
1 listed by FDA for this FEI, latest Oct 20, 2015
Import refusals
1

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
Jan 17, 2020Voluntary Action Indicated (VAI)Equipment and utensils - Design and maintenance (21 CFR 117.40)
Process Controls Corrective Action Proced: Estab Implement (21 CFR 117.150(a)(1))
Feb 20, 2015Official Action Indicated (OAI)No citations listed

Facility details

Company
FLECHARD S.A.S.
Location
Zi La Chapelle D' Andaine (FR)
Source
inspections

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