FDA Inspection 1113967 — Alfasigma SPA

Alfasigma SPA — FEI 3003911081

The FDA completed an inspection of Alfasigma SPA on January 18, 2019 in Alanno. 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
January 18, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alanno (Italy)

Additional Details

Mutual Recognition Agreement (MRA)