Company
United StatesVela Operations USA, Inc., Salt Lake City, UT – FDA Inspections
Inspection records and compliance data for Vela Operations USA, Inc. in Salt Lake City, Utah. 3 FDA inspections on record, last inspected June 01, 2022.
Company Profile
This profile covers Vela Operations USA, Inc. based in Salt Lake City, Utah, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected February 27, 2013. Last inspected June 1, 2022.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Documentation1 inspection
- Investigation of device failures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 1, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1170884 |
| January 7, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 909337 |
| February 27, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 820021 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Vela Operations USA, Inc.
FEI Number
3009071564
Address
2441 S 3850 W Ste A, Salt Lake City, Utah 84120, United States
Country
United States
ID: 7ac8d550-3861-49fc-9648-d8ba6625eb7f