FDA inspection

G3 Medical, Inc.: FDA inspection ending Aug 24, 2009

FDA inspection 610839 · Official Action Indicated (OAI) · Asheville, NC

Key facts

Inspection ID 610839
Firm G3 Medical, Inc.
FEI number 3004726911
Address 81 Thompson St
City Asheville
State NC
ZIP 28803
Country United States
Fiscal year 2009
Inspection end date Aug 24, 2009
Classification Official Action Indicated (OAI)
Project area Postmarket Assurance: Devices
Product type Devices
Warning letter 80284

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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