Company
United StatesCardiac Designs Inc., Round Rock, TX – FDA Inspections
Inspection records and compliance data for Cardiac Designs Inc. in Round Rock, Texas. 1 FDA inspection on record, 1 warning letter, last inspected June 29, 2016.
Company Profile
This profile covers Cardiac Designs Inc. based in Round Rock, Texas, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected June 29, 2016.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 29, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 976041 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cardiac Designs Inc.
FEI Number
3010665082
Address
1104 S Mays St Ste 219, Round Rock, Texas 78664, United States
Country
United States
ID: b07f007e-c575-49f5-af95-9c98f3ff854d