FDA inspection

Amgen Technology Ireland UC: FDA inspection ending Dec 8, 2015

FDA inspection 958535 · No Action Indicated (NAI) · Dun Laoghaire

Key facts

Inspection ID 958535
Firm Amgen Technology Ireland UC
FEI number 3002808497
Address Pottery Road
City Dun Laoghaire
Fiscal year 2016
Inspection end date Dec 8, 2015
Classification No Action Indicated (NAI)
Project area New Drug Evaluation
Product type Drugs

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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