FDA 483 - GRAMERCY EXTREMITY ORTHOPEDICS - October 24, 2025

GRAMERCY EXTREMITY ORTHOPEDICS in Richardson, TX, a manufacturer of class I and II medical devices, was cited for failing to adequately establish process control procedures. Specifically, the firm did not include titanium plate implants in their sterilization procedure's dose audit requirements and failed to conduct these audits as specified before distributing finished devices. This indicates a significant lapse in ensuring product conformance to specifications.