FDA Inspection 1201111 — Organon Heist

Organon Heist — FEI 3003974846

The FDA completed an inspection of Organon Heist on July 7, 2019 in Heist-Op-Den-Berg. 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
July 7, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Heist-Op-Den-Berg (Belgium)

Additional Details

Mutual Recognition Agreement (MRA)