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Boiron Freres SAS FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Boiron Freres SAS has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Boiron Freres SAS, the most recent on Apr 18, 2012.

What these totals cover: FDA records filed under the name "Boiron Freres SAS" and its spelling variant "Boiron Freres".

Latest inspection: Jun 7, 2022 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Boiron Freres SAS FDA Warning Letters

1 warning letter on Apr 18, 2012.

Issued	Subject	Issuing office	Close-out letter
Apr 18, 2012

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

2 inspections from Dec 16, 2011 to Jun 7, 2022.

Date	Site	Product	Classification	FEI
Jun 7, 2022	Chateauneuf-Sur-Isere, France	Food/Cosmetics	No Action Indicated (NAI)	3008468512
Dec 16, 2011	Chateauneuf-Sur-Isere, France	Food/Cosmetics	Official Action Indicated (OAI)	3008468512

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Boiron Freres SAS: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 18, 2012.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3008468512	Chateauneuf-Sur-Isere, France	2	Jun 7, 2022

Boiron Freres SAS and the FDA: common questions

Has Boiron Freres SAS received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Boiron Freres SAS. The most recent is dated Apr 18, 2012.

Has Boiron Freres SAS received an FDA Form 483?

FDA has not published a Form 483 for "Boiron Freres SAS" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Boiron Freres SAS?

The most recent FDA inspection on file ended Jun 7, 2022 at Chateauneuf-Sur-Isere, France and was classified NAI. FDA has 2 inspections of Boiron Freres SAS on file, 1 of them classified OAI (official action indicated).

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