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Boiron Freres SAS FDA Inspection Record

FEI 3008468512 · Inspections, Form 483s, warning letters and import refusals

Boiron Freres SAS is an FDA-inspected facility (FEI 3008468512) located in Chateauneuf-Sur-Isere, FR. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jun 7, 2022: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Dec 16, 2011
Warning letters
1 listed by FDA for this FEI, latest Apr 18, 2012
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 7, 2022No Action Indicated (NAI)No citations listed
Dec 16, 2011Official Action Indicated (OAI)HACCP plan - food hazards not listed (21 CFR 120.8(b)(1))
HACCP plan - not validated (21 CFR 120.11(b))
Process controls - HACCP plan - 5 log reduction (21 CFR 120.24(a))

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Boiron Freres SAS
Location
Chateauneuf-Sur-Isere (FR)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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