FDA Inspection 1215892 — Merck Serono S.p.A.

Merck Serono S.p.A. — FEI 3003581732

The FDA completed an inspection of Merck Serono S.p.A. on March 17, 2023 in Modugno. 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 17, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Modugno (Italy)

Additional Details

Mutual Recognition Agreement (MRA)