FDA inspection

Horizon Therapeutics Ireland DAC: FDA inspection ending Dec 14, 2023

FDA inspection 1238069 · Voluntary Action Indicated (VAI) · Waterford

Key facts

Inspection ID 1238069
Firm Horizon Therapeutics Ireland DAC
FEI number 3020007539
Address Butlerstown North, Cork Road, Waterford Business & Technology Ida Park
City Waterford
Fiscal year 2024
Inspection end date Dec 14, 2023
Classification Voluntary Action Indicated (VAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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