FDA Inspection 1207513 — Gedeon Richter Nyrt.

Gedeon Richter Nyrt. — FEI 3002806761

The FDA completed an inspection of Gedeon Richter Nyrt. on June 3, 2022 in Budapest. 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 3, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Budapest (Hungary)

Additional Details

Mutual Recognition Agreement (MRA)