FDA 483 - Truemed Group LLC - April 28, 2025

Truemed Group LLC, a medical device specification developer in The Woodlands, TX, was cited for significant quality system deficiencies during an FDA inspection. Observations included the failure to establish a Design History File for its orthopedic implant, inadequate validation of quality system software, and a lack of maintained Medical Device Reporting (MDR) and distribution record procedures, with the latter two being repeat observations. The findings indicate systemic issues in design control, software validation, and regulatory reporting.