Vycor Medical, Inc. / NovaVision Vision Technology, Inc.

Form 483

Boca Raton, Florida, United StatesFEI 3005880844Issued December 05, 2012

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3005880844.

Observations4

Issue DateDecember 05, 2012

StatusNo Warning Letter

Related Inspections3

Establishment Details

Firm: Vycor Medical, Inc. / NovaVision Vision Technology, Inc.
Location: Boca Raton, Florida, United States
FEI Number: 3005880844
Product Type: Devices
Issue Date: December 05, 2012
Country: United States

Inspection History, 2010 to 2017

NAI1

VAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Vycor Medical, Inc. / NovaVision Vision Technology, Inc. FDA Form 483, Boca Raton, Florida, December 5, 2012