FDA Inspection 1099286 — ACS Dobfar SPA (Plant #2)

ACS Dobfar SPA (Plant #2) — FEI 3002806297

The FDA completed an inspection of ACS Dobfar SPA (Plant #2) on March 1, 2019 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
March 1, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tribiano (Italy)

Additional Details

Mutual Recognition Agreement (MRA)