FDA inspection

Vycor Medical, Inc. / NovaVision Vision Technology, Inc.: FDA inspection ending Dec 5, 2012

FDA inspection 810422 · Voluntary Action Indicated (VAI) · Boca Raton, FL

Key facts

Inspection ID 810422
Firm Vycor Medical, Inc. / NovaVision Vision Technology, Inc.
FEI number 3005880844
Address 951 Broken Sound Pkwy Ste 320
City Boca Raton
State FL
ZIP 33487
Country United States
Fiscal year 2013
Inspection end date Dec 5, 2012
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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