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FDA Inspection 1217117 — Astellas Pharma US Inc.

Astellas Pharma US Inc. — FEI 1000036852

The FDA completed an inspection of Astellas Pharma US Inc. on August 14, 2023 in Northbrook, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 14, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Northbrook, IL (United States)

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 1108572 (VAI Fri Oct 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1058496 (NAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030399 (NAI Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 864055 (NAI Wed Feb 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769358 (VAI Mon Feb 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources