FDA inspection

Genia Medical, Inc.: FDA inspection ending Apr 17, 2017

FDA inspection 1012875 · Voluntary Action Indicated (VAI) · Orlando, FL

Key facts

Inspection ID 1012875
Firm Genia Medical, Inc.
FEI number 3004157007
Address 121 S Orange Ave Ste 1000
City Orlando
State FL
ZIP 32801
Country United States
Fiscal year 2017
Inspection end date Apr 17, 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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