FDA 483 - Nyxoah S.A. Milmort - November 15, 2024

An FDA inspection of Nyxoah S.A. Milmort, a medical device manufacturer, identified a significant deficiency regarding the documentation of process validation and equipment qualification. The firm failed to adequately document these critical activities, indicating a potential weakness in their quality system. This suggests a moderate severity issue related to ensuring product quality and safety.