FDA inspection

Gentian AS: FDA inspection ending Aug 20, 2015

FDA inspection 941234 · Voluntary Action Indicated (VAI) · Moss

Key facts

Inspection ID 941234
Firm Gentian AS
FEI number 3006801241
Address Bjornasveien 5
City Moss
Country Norway
Fiscal year 2015
Inspection end date Aug 20, 2015
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

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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