FDA Inspection
Vycor Medical, Inc. / NovaVision Vision Technology, Inc.Vycor Medical, Inc. / NovaVision Vision Technology, Inc. – FDA Inspection, Dec 5, 2012
Record Details
This FDA Inspection record concerns Vycor Medical, Inc. / NovaVision Vision Technology, Inc., with an inspection on December 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 5, 2012
- Product Type
- Devices
View Company Profile
ID · e51e322a-d920-4916-b8fd-a9fc3d103f49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 810422
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vycor Medical, Inc. / NovaVision Vision Technology, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2018 | Not classified | Florida District Office | |
| July 19, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 2, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vycor Medical, Inc. / NovaVision Vision Technology, Inc.
- FDA Inspection 1105446 - 2018-11-06
- FDA Inspection 1018431 - 2017-07-19
- FDA Inspection 659013 - 2010-04-02
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