FDA Inspection 1159215 — Merck Serono S.p.A.
The FDA completed an inspection of Merck Serono S.p.A. on March 29, 2019 in Guidonia Montecelio. 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 29, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guidonia Montecelio (Italy)
Additional Details
Mutual Recognition Agreement (MRA)