FDA Inspection
Torax Medical, Inc.Torax Medical, Inc. – FDA Inspection, Nov 19, 2025
Record Details
This FDA Inspection record concerns Torax Medical, Inc., with an inspection on November 19, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ccc29ecd-2269-49cf-9671-e9e01217643b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1291992
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of Torax Medical, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 20, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Torax Medical, Inc.
- FDA Inspection 1223685 - 2023-11-16
- FDA Inspection 1120010 - 2020-02-20
- FDA Inspection 991763 - 2016-11-08
- FDA Inspection 825848 - 2013-03-28
- FDA Inspection 714721 - 2011-03-14
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