FDA inspection

Astellas Ireland Co Ltd: FDA inspection ending Nov 8, 2019

FDA inspection 1127849 · Voluntary Action Indicated (VAI) · Killorglin

Key facts

Inspection ID 1127849
Firm Astellas Ireland Co Ltd
FEI number 3002807020
Address Bansha
City Killorglin
Country Ireland
Fiscal year 2020
Inspection end date Nov 8, 2019
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
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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