FDA Inspection 1202245 — Alfasigma S.p.A.

Alfasigma S.p.A. — FEI 3002808171

The FDA completed an inspection of Alfasigma S.p.A. on May 28, 2021 in Pomezia. 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
May 28, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pomezia (Italy)

Additional Details

Mutual Recognition Agreement (MRA)