FDA 483 - Woven Orthopedic Technologies, LLC - July 23, 2025

An FDA inspection of Woven Orthopedic Technologies in Stamford, CT, revealed significant deficiencies in their quality system for medical devices. Observations included a lack of established process control procedures for sterilization of the Ogmend Implant Enhancement System, unestablished procedures for handling and evaluating complaints, and failure to upload Unique Device Identifier (UDI) information to the GUDID database. These issues indicate a need for improved quality management and regulatory compliance.