Company
United StatesVycor Medical, Inc. / NovaVision Vision Technology, Inc., Boca Raton, FL – FDA Inspections
Inspection records and compliance data for Vycor Medical, Inc. / NovaVision Vision Technology, Inc. in Boca Raton, Florida. 4 FDA inspections on record, 2 Form 483s, last inspected November 06, 2018.
Company Profile
This profile covers Vycor Medical, Inc. / NovaVision Vision Technology, Inc. based in Boca Raton, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 2, 2010. Last inspected November 6, 2018.
Most cited issue areas
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation of validated process performance1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 6, 2018 | Not classified | Medical Devices & Rad Health | 1105446 |
| July 19, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1018431 |
| December 5, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 810422 |
| April 2, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 659013 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Vycor Medical, Inc. / NovaVision Vision Technology, Inc.
FEI Number
3005880844
Address
951 Broken Sound Pkwy Ste 320, Boca Raton, Florida 33487, United States
Country
United States
ID: 546afeff-b19f-422c-8a31-13499f9ba215