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FDA Inspection 1231467 — Kedrion Biopharma Inc.

Kedrion Biopharma Inc. — FEI 3003683714

The FDA completed an inspection of Kedrion Biopharma Inc. on March 27, 2024 in Melville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 27, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Melville, NY (United States)

Facility

Other inspections at this facility

  • 1148187 (VAI Fri Jun 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064655 (VAI Wed Aug 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900509 (VAI Mon Sep 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801013 (VAI Thu Aug 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 610974 (VAI Tue Jul 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources