FDA inspection

Optos, PLC: FDA inspection ending Jan 26, 2017

FDA inspection 1004971 · Voluntary Action Indicated (VAI) · Dunfermline

Key facts

Inspection ID 1004971
Firm Optos, PLC
FEI number 3003060634
Address Queensferry House, Carnegie Campus, Enterprise Way
City Dunfermline
Country United Kingdom
Fiscal year 2017
Inspection end date Jan 26, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 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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