Company
United StatesHelio USA Inc, San Jose, CA – FDA Inspections
Inspection records and compliance data for Helio USA Inc in San Jose, California. 3 FDA inspections on record, last inspected July 06, 2016.
Company Profile
This profile covers Helio USA Inc based in San Jose, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 26, 2011. Last inspected July 6, 2016.
Most cited issue areas
- Design control - no procedures3 inspections
- Lack of or inadequate complaint procedures3 inspections
- Lack of or inadequate procedures3 inspections
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 6, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 977018 |
| May 12, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 925740 |
| September 26, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 747431 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Helio USA Inc
FEI Number
1000135119
Address
816 Charcot Ave, San Jose, California 95131, United States
Country
United States
ID: 5c2e6761-b856-452e-8b37-2ecc0aa37dc4