FDA Inspection
Sotera Wireless, Inc.Sotera Wireless, Inc. – FDA Inspection, Jul 26, 2024
Record Details
This FDA Inspection record concerns Sotera Wireless, Inc., with an inspection on July 26, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 5cb6fb9a-35c8-4154-8b31-f6c240521a79
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1244750
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sotera Wireless, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sotera Wireless, Inc.
- FDA Inspection 1083276 - 2019-03-06
- FDA Inspection 890498 - 2014-08-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.