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Warning Letter

Case 485363 — FEI 3000718824

Facility

Recent inspections

  • 1230144 (VAI Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062610 (VAI Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021385 (VAI Sat Aug 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947268 (OAI Thu Nov 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834098 (VAI Fri May 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Horizon Pharmaceuticals, Inc.
Date
December 23, 2016
Fiscal Year
2017
Product Type
Drugs
Center
CDER
Location
Riviera Beach, FL (United States)