FDA inspection

Vycor Medical, Inc. / NovaVision Vision Technology, Inc.: FDA inspection ending Jul 19, 2017

FDA inspection 1018431 · Voluntary Action Indicated (VAI) · Boca Raton, FL

Key facts

Inspection ID 1018431
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 2017
Inspection end date Jul 19, 2017
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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