FDA 483 - Nexxt Spine, LLC - August 11, 2025

Nexxt Spine, LLC in Noblesville, IN, was inspected and received a Form FDA 483 with four observations related to significant quality system deficiencies. The firm failed to validate critical cleaning processes, lacked adequate monitoring for validated processes, and had deficient cleanroom environmental controls. Additionally, the risk analysis procedures were found to be inadequate, indicating a moderate level of severity in quality system non-compliance.