Company
United StatesScion Cardio-Vascular Inc., Miami, FL – FDA Inspections
Inspection records and compliance data for Scion Cardio-Vascular Inc. in Miami, Florida. 3 FDA inspections on record, last inspected February 22, 2019.
Company Profile
This profile covers Scion Cardio-Vascular Inc. based in Miami, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected July 26, 2012. Last inspected February 22, 2019.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Info which facilitates timely FDA follow-up1 inspection
- Investigation of device failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 22, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1082327 |
| July 30, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 936398 |
| July 26, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 794275 |
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
Scion Cardio-Vascular Inc.
FEI Number
1000113395
Address
14256 SW 119th Ave, Miami, Florida 33186, United States
Country
United States
ID: 342f6ed9-eaea-4288-93f0-b2bfd2a3e1c9