FDA inspection

SK Biotek Ireland Ltd.: FDA inspection ending Feb 25, 2016

FDA inspection 963209 · Voluntary Action Indicated (VAI) · Swords

Key facts

Inspection ID 963209
Firm SK Biotek Ireland Ltd.
FEI number 3002806583
Address Watery Lane
City Swords
Country Ireland
Fiscal year 2016
Inspection end date Feb 25, 2016
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
  • 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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