Company
United StatesSotera Wireless, Inc., Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Sotera Wireless, Inc. in Carlsbad, California. 3 FDA inspections on record, 1 Form 483, last inspected July 26, 2024.
Company Profile
This profile covers Sotera Wireless, Inc. based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 7, 2014. Last inspected July 26, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1244750 |
| March 6, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1083276 |
| August 7, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 890498 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sotera Wireless, Inc.
FEI Number
3009673645
Address
5841 Edison Pl Ste 140, Carlsbad, California 92008, United States
Country
United States
ID: fa783d65-c9ac-4c6e-a0e9-00eca02eb69f