Company
United StatesU-systems Inc, Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for U-systems Inc in Sunnyvale, California. 4 FDA inspections on record, last inspected March 31, 2017.
Company Profile
This profile covers U-systems Inc based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 30, 2008. Last inspected March 31, 2017.
Most cited issue areas
- Design verification procedures1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 31, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1006662 |
| September 10, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 849549 |
| January 26, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 766597 |
| October 30, 2008 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 546257 |
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
U-systems Inc
FEI Number
3003248267
Address
447 Indio Way, Sunnyvale, California 94085, United States
Country
United States
ID: ece80e1d-895e-4cef-ad7d-54cbf0f5d749