FDA 483 - Tactical Medical Systems Thermal Management Group - August 08, 2025

Tactical Medical Systems Thermal Management Group in Oviedo, FL, was inspected regarding its manufacturing of class 2 Portable Expeditionary Refrigerators. The inspection revealed a severe lack of fundamental quality system procedures, including risk analysis, design controls, nonconforming product control, purchasing, complaint handling, quality audits, management review, CAPA, MDR, and training. Additionally, the firm failed to implement Unique Device Identifier (UDI) labeling and GUDID registration for its devices.