FDA Inspection 1056552 — IBSA Institut Biochimique SA

IBSA Institut Biochimique SA — FEI 3002864272

The FDA completed an inspection of IBSA Institut Biochimique SA on June 22, 2018 in Pazzallo. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 22, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pazzallo (Switzerland)

Citations

IDCFRDescription
192021 CFR 211.166(a)(3)Valid stability test methods