FDA Inspection
Tactical Medical Systems Thermal Management GroupTactical Medical Systems Thermal Management Group – FDA Inspection, Oct 14, 2026
Record Details
This FDA Inspection record concerns Tactical Medical Systems Thermal Management Group, with an inspection on October 14, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 14, 2026
- Product Type
- Devices
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ID · f9bfcd7c-24e0-44f4-a61f-6003455b0916
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1341108
- Project area
- Compliance: Devices
FDA Citations
6- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 6.2(a)Personnel training not provided
- ISO 13485:2016 Clause 8.5.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.5.1QMS not reviewed by top management at documented planned intervals
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 7.1Supplier performance not monitored
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Other FDA inspections of Tactical Medical Systems Thermal Management Group
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | VAI | Florida District Office | Compliance: Medical Devices |
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