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Warning Letter

Case 710275 — FEI 1000132299

Facility

Recent inspections

  • 1265549 (OAI Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118943 (VAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985050 (VAI Wed Sep 14 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837816 (VAI Mon Jun 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 742136 (OAI Fri Aug 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Owen Biosciences Inc.
Date
October 30, 2025
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
Baton Rouge, LA (United States)