FDA Inspection 1271522 — N.V. Organon

N.V. Organon — FEI 3002806821

The FDA completed an inspection of N.V. Organon on August 25, 2022 in Oss. 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
August 25, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oss (Netherlands)

Additional Details

Mutual Recognition Agreement (MRA)