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FDA Inspection 1118104 — Merck Serono S.p.A.

Merck Serono S.p.A. — FEI 3003581732

The FDA completed an inspection of Merck Serono S.p.A. on June 22, 2018 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
June 22, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Modugno (Italy)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

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  • 1053903 (VAI Fri May 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980565 (VAI Tue May 10 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891189 (VAI Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources