FDA Inspection
Sotera Wireless, Inc.Sotera Wireless, Inc. – FDA Inspection, Mar 6, 2019
Record Details
This FDA Inspection record concerns Sotera Wireless, Inc., with an inspection on March 6, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6d7baddd-0e14-4eff-bbec-0990761fb60b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083276
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Sotera Wireless, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sotera Wireless, Inc.
- FDA Inspection 1244750 - 2024-07-26
- FDA Inspection 890498 - 2014-08-07
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