FDA 483 - Nemcomed FW LLC dba Avalign Instruments and Implants - January 16, 2025

An FDA inspection of Nemcomed FW LLC dba Avalign Instruments and Implants in Fort Wayne, IN, identified a significant issue regarding the inadequate documentation of acceptance activities. Specifically, the firm failed to consistently record the equipment used during these activities, which is crucial for investigating nonconforming products. This deficiency was observed in sampled Device History Records, indicating a systemic problem with record-keeping for critical manufacturing processes.