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

Source: https://www.keypedia.com/records/483/woven-orthopedic-technologies-llc/15c9448b-0a74-4ab5-a5aa-bddd3b8b48bd

> FDA 483 for Woven Orthopedic Technologies, LLC on July 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Woven Orthopedic Technologies, LLC
- Inspection Date: 2025-07-23
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/woven-orthopedic-technologies-llc/c962267b-77a2-42d0-b91a-2542c0db7440

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144