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FDA Inspection 1264264 — Catalent Indiana, LLC

Catalent Indiana, LLC — FEI 3005949964

The FDA completed an inspection of Catalent Indiana, LLC on July 14, 2025 in Bloomington, IN. 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
July 14, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bloomington, IN (United States)

Facility

Other inspections at this facility

  • 1224264 (VAI Wed Nov 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1178819 (VAI Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111350 (VAI Fri Oct 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063669 (NAI Fri Aug 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040034 (VAI Fri Jan 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources