FDA Inspection 760668 — Boiron Freres SAS

Boiron Freres SAS — FEI 3008468512

The FDA completed an inspection of Boiron Freres SAS on December 16, 2011 in Chateauneuf-Sur-Isere. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 16, 2011
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Chateauneuf-Sur-Isere (France)

Citations

IDCFRDescription
1274521 CFR 120.8(b)(1)HACCP plan - food hazards not listed
994721 CFR 120.11(b)HACCP plan - not validated
996121 CFR 120.24(a)Process controls - HACCP plan - 5 log reduction