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1021385

Horizon Pharmaceuticals, Inc. — FEI 3000718824

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 5, 2017
Fiscal Year
2017
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))
  • 1062610 (VAI Fri Aug 17 2018 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
126321 CFR 211.68(b)Computer control of master formula records
145121 CFR 211.113(b)Procedures for sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
195721 CFR 211.180(e)(2)Review of problem drugs
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure