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1062610

Horizon Pharmaceuticals, Inc. — FEI 3000718824

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 17, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Riviera Beach, FL (United States)

Facility

Other inspections at this facility

  • 1230144 (VAI Fri Feb 16 2024 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))
  • 747247 (VAI Mon Sep 26 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
138421 CFR 211.101(c)Weighing/measuring/subdividing supervision
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
358821 CFR 211.110(a)(3)Mixing adequacy