FDA Inspection
Vycor Medical, Inc. / NovaVision Vision Technology, Inc.Vycor Medical, Inc. / NovaVision Vision Technology, Inc. – FDA Inspection, Jul 19, 2017
Record Details
This FDA Inspection record concerns Vycor Medical, Inc. / NovaVision Vision Technology, Inc., with an inspection on July 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 19, 2017
- Product Type
- Devices
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ID · a2bc1c95-aba3-4c4e-a12d-988d042f5a56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018431
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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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 | |
| December 5, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 810422 - 2012-12-05
- FDA Inspection 659013 - 2010-04-02
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