FDA 483 - Viper Technologies, LLC dba Avalign Thortex - September 24, 2021

An FDA inspection of Viper Technologies, LLC dba Avalign Thortex in Portland, OR, revealed significant deficiencies in their quality system. The firm failed to adequately establish and implement procedures for corrective and preventive actions, complaint handling, and control of nonconforming product. Additionally, issues were identified with the establishment and implementation of device history record procedures, indicating systemic quality management failures.