FDA 483 - Woven Orthopedic Technologies, LLC - July 23, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 15c9448b-0a74-4ab5-a5aa-bddd3b8b48bd