FDA Inspection 1341108 — Tactical Medical Solutions, Thermal Management Group
The FDA completed an inspection of Tactical Medical Solutions, Thermal Management Group on Oct 14, 2026 in Oviedo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 14, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oviedo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23072 | ISO 13485:2016 Clause 6.2(b) | Personnel training not provided |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |