FDA 483 - Truemed Group LLC - June 05, 2019

Truemed Group LLC, a specification developer of Class 2 implantable orthopedic medical devices in Spring, TX, was cited for significant quality system deficiencies during an FDA inspection. Observations included a lack of written Medical Device Reporting procedures, device history records not conforming to master records, and inadequate maintenance of distribution records for devices shipped from Mexico to the U.S. These issues indicate a failure to ensure device quality and traceability.