FDA Inspection 1194303 — ACS Dobfar SPA (Plant #2)

ACS Dobfar SPA (Plant #2) — FEI 3002806297

The FDA completed an inspection of ACS Dobfar SPA (Plant #2) on December 3, 2021 in Tribiano. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 3, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tribiano (Italy)

Additional Details

Mutual Recognition Agreement (MRA)