FDA Inspection 1017861 — Boiron

Boiron — FEI 3004611192

The FDA completed an inspection of Boiron on July 7, 2017 in Messimy. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 7, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Messimy (France)

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
192821 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
240121 CFR 211.194(a)(4)Complete Test Data
434221 CFR 211.142(b)Storage under appropriate conditions