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1230144

Horizon Pharmaceuticals, Inc. — FEI 3000718824

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 16, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Riviera Beach, FL (United States)

Facility

Other inspections at this facility

  • 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))
  • 747247 (VAI Mon Sep 26 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
107921 CFR 211.22(a)Contract drug products--lack of responsibility
110521 CFR 211.22(d)Procedures not in writing, fully followed
142121 CFR 211.42(c)(10)Aseptic Processing Area
200921 CFR 211.188Prepared for each batch, include complete information
240621 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
360321 CFR 211.160(b)Scientifically sound laboratory controls
361021 CFR 211.160(b)(3)Drug product sample