FDA Inspection 1271041 — Astellas Ireland Co., Ltd.

Astellas Ireland Co., Ltd. — FEI 3005403283

The FDA completed an inspection of Astellas Ireland Co., Ltd. on June 17, 2022 in Dublin 15. 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 17, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dublin 15 (Ireland)

Additional Details

Mutual Recognition Agreement (MRA)