FDA 483 - CROSSROADS EXTREMITY SYSTEMS LLC - August 26, 2022

CROSSROADS EXTREMITY SYSTEMS LLC in Memphis, TN, was inspected from August 22-26, 2022, and received a Form 483 with three observations. The inspection revealed issues with incomplete product validation for the MiniBunion Implant System, a lack of procedures for GUDID labeling requirements, and inadequate documentation and monitoring of environmental controls. These observations indicate deficiencies in the firm's quality system.