FDA Inspection 978093 — Intercos Europe SpA

Intercos Europe SpA — FEI 3005291719

The FDA completed an inspection of Intercos Europe SpA on June 24, 2016 in Dovera. 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 24, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dovera (Italy)

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures